DailyMed - MODEL AA-8565CV-ACT MODEL AA-8565CV- kit

NHRIC Code(s): 27860-013-16
Packager: Aerospace Accessory Service, Inc
This is a repackaged label.
Source NDC Code(s): 50844-957

Category: MEDICAL DEVICE
DEA Schedule: None
Marketing Status: Exempt device

Drug Label Information

Updated May 18, 2021

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Aerospace Accessory Service

Aerospace Accessory Service

P/N:

S/N:

EXP:

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INGREDIENTS AND APPEARANCE

MODEL AA-8565CV-ACT MODEL AA-8565CV
emergency response safety kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:27860-013

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:27860-013-16	1 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1		1
Part 2		1
Part 3		1
Part 4		1
Part 5		1
Part 6		1
Part 7		1
Part 8		1
Part 9		1
Part 10		1
Part 11		1
Part 12		1
Part 13		1
Part 14		1
Part 15		1
Part 16		1
Part 17		1
Part 18		1
Part 19		1
Part 20		1
Part 21		1
Part 22		1
Part 23		1
Part 24		1
Part 25		1
Part 26		1
Part 27		1
Part 28		1
Part 29		1
Part 30		1
Part 31		1

Part 1 of 31

SODIUM CHLORIDE
sodium chloride injection, solution

Product Information
Item Code (Source)	NDC:0338-0049
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	9 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA016677	12/09/1970

Part 2 of 31

SODIUM CHLORIDE
sodium chloride injection, solution

Product Information
Item Code (Source)	NDC:0264-7800
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	0.9 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019635	03/09/1988

Part 3 of 31

ATROPINE SULFATE
atropine sulfate injection, solution

Product Information
Item Code (Source)	NDC:0409-4910
Route of Administration	INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ENDOTRACHEAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	ATROPINE SULFATE	0.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
SULFURIC ACID (UNII: O40UQP6WCF)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021146	01/19/2006

Part 4 of 31

ATROPINE SULFATE
atropine sulfate injection

Product Information
Item Code (Source)	NDC:76329-3339
Route of Administration	PARENTERAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Atropine Sulfate (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I)	Atropine Sulfate	0.1 mg in 1 mL

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/01/2000

Part 5 of 31

DEXTROSE MONOHYDRATE
dextrose monohydrate injection

Product Information
Item Code (Source)	NDC:76329-3301
Route of Administration	PARENTERAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	500 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		06/01/2000

Part 6 of 31

DEXTROSE
dextrose monohydrate injection, solution

Product Information
Item Code (Source)	NDC:0409-6648
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK)	DEXTROSE MONOHYDRATE	25 g in 50 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA019445	12/02/2005

Part 7 of 31

NITROGLYCERIN
nitroglycerin tablet

Product Information
Item Code (Source)	NDC:68462-639
Route of Administration	SUBLINGUAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)	NITROGLYCERIN	0.4 mg

Ingredient Name	Strength
Inactive Ingredients
CALCIUM STEARATE (UNII: 776XM7047L)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)

Product Characteristics
Color	white (white to off white)	Score	no score
Shape	ROUND (Flat faced)	Size	4mm
Flavor		Imprint Code	2;C
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA206391	08/19/2017

Part 8 of 31

DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride injection

Product Information
Item Code (Source)	NDC:0641-0376
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BENZETHONIUM CHLORIDE (UNII: PH41D05744)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA080817	11/27/1972

Part 9 of 31

EPINEPHRINE
epinephrine injection, solution, concentrate

Product Information
Item Code (Source)	NDC:54288-103
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	Epinephrine	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Sodium Chloride (UNII: 451W47IQ8X)
Hydrochloric Acid (UNII: QTT17582CB)
Water (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA205029	08/08/2014

Part 10 of 31

ALCOHOL PREP
isopropyl alcohol swab

Product Information
Item Code (Source)	NDC:67777-121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	0.7 mL in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	07/01/2010

Part 11 of 31

MOORE MEDICAL NON ASPIRIN
acetaminophen tablet, film coated

Product Information
Item Code (Source)	NDC:55670-467
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg

Ingredient Name	Strength
Inactive Ingredients
HYPROMELLOSES (UNII: 3NXW29V3WO)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	AZ;234
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	12/30/2008

Part 12 of 31

ASPIRIN
aspirin tablet, film coated

Product Information
Item Code (Source)	NDC:55670-131
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
MINERAL OIL (UNII: T5L8T28FGP)
STARCH, CORN (UNII: O8232NY3SJ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white (white)	Score	no score
Shape	ROUND (ROUND)	Size	10mm
Flavor		Imprint Code	TCL;011
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part343	12/30/2008	08/31/2022

Part 13 of 31

MOOREBRAND ASPIRIN
aspirin tablet, film coated

Product Information
Item Code (Source)	NDC:55670-616(NDC:50844-957)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E)	ASPIRIN	325 mg

Ingredient Name	Strength
Inactive Ingredients
STARCH, CORN (UNII: O8232NY3SJ)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	Aspirin;44;157
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part343	10/05/2020

Part 14 of 31

VENTOLIN HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC:0173-0682
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Ingredient Name	Strength
Inactive Ingredients
NORFLURANE (UNII: DH9E53K1Y8)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA020983	06/09/2006

Part 15 of 31

ALBUTEROL SULFATE HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC:66993-019
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Ingredient Name	Strength
Inactive Ingredients
NORFLURANE (UNII: DH9E53K1Y8)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA authorized generic	NDA020983	01/15/2019

Part 16 of 31

ALBUTEROL SULFATE
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC:45802-088
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Ingredient Name	Strength
Inactive Ingredients
ALCOHOL (UNII: 3K9958V90M)
NORFLURANE (UNII: DH9E53K1Y8)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203760	02/26/2020

Part 17 of 31

ALBUTEROL SULFATE HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC:0093-3174
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Ingredient Name	Strength
Inactive Ingredients
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021457	01/16/2019

Part 18 of 31

ALBUTEROL SULFATE
albuterol sulfate inhalant

Product Information
Item Code (Source)	NDC:69097-142
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	108 ug

Ingredient Name	Strength
Inactive Ingredients
OLEIC ACID (UNII: 2UMI9U37CP)
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA209959	04/08/2020

Part 19 of 31

ALBUTEROL SULFATE
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC:0254-1007
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	108 ug

Ingredient Name	Strength
Inactive Ingredients
OLEIC ACID (UNII: 2UMI9U37CP)
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA authorized generic	NDA020503	04/03/2019

Part 20 of 31

PROAIR HFA
albuterol sulfate aerosol, metered

Product Information
Item Code (Source)	NDC:59310-579
Route of Administration	RESPIRATORY (INHALATION)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)	ALBUTEROL	90 ug

Ingredient Name	Strength
Inactive Ingredients
NORFLURANE (UNII: DH9E53K1Y8)
ALCOHOL (UNII: 3K9958V90M)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA021457	12/03/2012

Part 21 of 31

POVIDONE-IODINE
povidone-iodine solution

Product Information
Item Code (Source)	NDC:46414-7777
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
NONOXYNOL-9 (UNII: 48Q180SH9T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/14/1976

Part 22 of 31

BZK PADS
benzalkonium chloride swab

Product Information
Item Code (Source)	NDC:67777-245
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/05/2011

Part 23 of 31

SOLU-CORTEF
hydrocortisone sodium succinate injection, powder, for solution

Product Information
Item Code (Source)	NDC:0009-0825
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	100 mg in 2 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA009866	04/27/1955

Part 24 of 31

SOLU-CORTEF
hydrocortisone sodium succinate injection, powder, for solution

Product Information
Item Code (Source)	NDC:0009-0011
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	100 mg in 2 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA009866	04/27/1955

Part 25 of 31

FUROSEMIDE
furosemide injection, solution

Product Information
Item Code (Source)	NDC:23155-473
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)	FUROSEMIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA203428	09/02/2014

Part 26 of 31

FUROSEMIDE
furosemide injection, solution

Product Information
Item Code (Source)	NDC:63323-280
Route of Administration	INTRAVENOUS, INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)	FUROSEMIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018902	07/12/2000

Part 27 of 31

FUROSEMIDE
furosemide injection, solution

Product Information
Item Code (Source)	NDC:36000-283
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5)	FUROSEMIDE	10 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA202747	02/06/2014

Part 28 of 31

PITOCIN
oxytocin injection

Product Information
Item Code (Source)	NDC:42023-116
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN)	OXYTOCIN	10 [iU] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACETIC ACID (UNII: Q40Q9N063P)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018261	02/01/2008

Part 29 of 31

OXYTOCIN
oxytocin injection, solution

Product Information
Item Code (Source)	NDC:63323-012
Route of Administration	INTRAVENOUS, INTRAMUSCULAR

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN)	OXYTOCIN	10 [USP'U] in 1 mL

Ingredient Name	Strength
Inactive Ingredients
ACETIC ACID (UNII: Q40Q9N063P)
CHLOROBUTANOL (UNII: HM4YQM8WRC)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA018248	08/10/2000

Part 30 of 31

PROMETHAZINE HYDROCHLORIDE
promethazine hydrochloride injection

Product Information
Item Code (Source)	NDC:0641-1495
Route of Administration	INTRAMUSCULAR, INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494)	PROMETHAZINE HYDROCHLORIDE	25 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
EDETATE DISODIUM (UNII: 7FLD91C86K)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
PHENOL (UNII: 339NCG44TV)
ACETIC ACID (UNII: Q40Q9N063P)
SODIUM ACETATE (UNII: 4550K0SC9B)
WATER (UNII: 059QF0KO0R)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA083312	09/19/1973

Part 31 of 31

METOPROLOL TARTRATE
metoprolol tartrate tablet, film coated

Product Information
Item Code (Source)	NDC:65862-062
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23)	METOPROLOL TARTRATE	25 mg

Ingredient Name	Strength
Inactive Ingredients
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE 2910 (6 MPA.S) (UNII: 0WZ8WG20P6)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Product Characteristics
Color	white	Score	2 pieces
Shape	ROUND	Size	7mm
Flavor		Imprint Code	C;73
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA077739	09/11/2007

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
exempt device	ABC	01/01/2015

Labeler - Aerospace Accessory Service, Inc (859100547)

Registrant - Aerospace Accessory Service, Inc (859100547)

Name	Address	ID/FEI	Business Operations
Establishment
Aerospace Accessory Service, Inc		859100547	manufacture, repack

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Published Date (What is this?)	Version	Files
May 19, 2021	3 (current)	download
May 6, 2021	2	download
Jan 19, 2021	1	download

	RxCUI	RxNorm NAME	RxTTY
1	105398	Solu-CORTEF 100 MG Injection	PSN
2	105398	hydrocortisone 100 MG Injection [Solu-Cortef]	SBD
3	105398	Solu-Cortef 100 MG Injection	SY
4	105398	Solu-Cortef (as hydrocortisone sodium succinate) 100 MG Injection	SY
5	198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN
6	198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD
7	198039	nitroglycerin 400 MCG Sublingual Tablet	SY
8	198039	NTG 0.4 MG Sublingual Tablet	SY
9	198039	TNG 0.4 MG Sublingual Tablet	SY
10	207315	Pitocin 10 UNT/ML Injectable Solution	PSN
11	207315	oxytocin 10 UNT/ML Injectable Solution [Pitocin]	SBD
12	207315	Pitocin 10 UNT/ML Injectable Solution	SY
13	212033	aspirin 325 MG Oral Tablet	PSN
14	212033	aspirin 325 MG Oral Tablet	SCD
15	212033	ASA 325 MG Oral Tablet	SY
16	238013	oxytocin 10 UNT/ML Injectable Solution	PSN
17	238013	oxytocin 10 UNT/ML Injectable Solution	SCD
18	238755	hydrocortisone sodium succinate 100 MG Injection	PSN
19	238755	hydrocortisone 100 MG Injection	SCD
20	238755	hydrocortisone (as hydrocortisone sodium succinate) 100 MG Injection	SY
21	312564	povidone-iodine 10 % Topical Solution	PSN
22	312564	povidone-iodine 100 MG/ML Topical Solution	SCD
23	312564	povidone-iodine 10 % (titratable iodine 1 % ) Topical Solution	SY
24	313782	acetaminophen 325 MG Oral Tablet	PSN
25	313782	acetaminophen 325 MG Oral Tablet	SCD
26	313782	APAP 325 MG Oral Tablet	SY
27	727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN
28	727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD
29	727517	50 ML dextrose 50 % Prefilled Syringe	SY
30	727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY
31	745752	ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN
32	745752	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]	SBD
33	745752	200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler	SY
34	745752	NDA021457 200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler	SY
35	745752	ProAir HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY
36	745752	ProAir HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUAT	SY
37	745752	ProAir HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY
38	797544	isopropyl alcohol 70 % Medicated Pad	PSN
39	797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD
40	797544	isopropyl alcohol 70 % Medicated Pad	SY
41	797544	isopropyl alcohol 70 % Topical Cloth	SY
42	797544	isopropyl alcohol 70 % Topical Swab	SY
43	801092	albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin	PSN
44	801092	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
45	801092	albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler	SY
46	801092	albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY
47	801092	albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin	SY
48	801095	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN
49	801095	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD
50	801095	NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler	SY
51	801095	Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY
52	801095	Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY
53	801095	Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY
54	859088	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN
55	859088	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD
56	859088	NDA020983 200 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler	SY
57	859088	Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUAT	SY
58	859088	Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY
59	866924	metoprolol tartrate 25 MG Oral Tablet	PSN
60	866924	metoprolol tartrate 25 MG Oral Tablet	SCD
61	992460	promethazine HCl 25 MG in 1 ML Injection	PSN
62	992460	1 ML promethazine hydrochloride 25 MG/ML Injection	SCD
63	992460	promethazine HCl 25 MG per 1 ML Injection	SY
64	1038558	benzalkonium chloride 0.13 % Medicated Pad	PSN
65	1038558	benzalkonium chloride 1.3 MG/ML Medicated Pad	SCD
66	1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Pad	SY
67	1038558	benzalkonium chloride 0.13 GM per 100 GM Topical Swab	SY
68	1038558	benzalkonium chloride 0.13 % Topical Swab	SY
69	1038558	benzalkonium chloride 1 ML per 750 ML Topical Swab	SY
70	1049633	diphenhydrAMINE HCl 50 MG/ML Injectable Solution	PSN
71	1049633	diphenhydramine hydrochloride 50 MG/ML Injectable Solution	SCD
72	1049633	diphenhydramine HCl 50 MG/ML Injectable Solution	SY
73	1190546	atropine sulfate 1 MG in 10 ML Prefilled Syringe	PSN
74	1190546	10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD
75	1190546	atropine sulfate 1 MG per 10 ML Prefilled Syringe	SY
76	1190552	atropine sulfate 0.5 MG in 5 ML Prefilled Syringe	PSN
77	1190552	5 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD
78	1190552	atropine sulfate 0.5 MG per 5 ML Prefilled Syringe	SY
79	1190552	atropine sulfate 500 MCG per 5 ML Prefilled Syringe	SY
80	1660014	EPINEPHrine 1 MG in 1 ML Injection	PSN
81	1660014	1 ML epinephrine 1 MG/ML Injection	SCD
82	1660014	epinephrine 1 MG per 1 ML Injection	SY
83	1719286	furosemide 100 MG in 10 ML Injection	PSN
84	1719286	10 ML furosemide 10 MG/ML Injection	SCD
85	1719286	furosemide 100 MG per 10 ML Injection	SY
86	1719287	furosemide 10 MG/ML Injection	SCD
87	1719290	furosemide 20 MG in 2 ML Injection	PSN
88	1719290	2 ML furosemide 10 MG/ML Injection	SCD
89	1719290	furosemide 20 MG per 2 ML Injection	SY
90	1719291	furosemide 40 MG in 4 ML Injection	PSN
91	1719291	4 ML furosemide 10 MG/ML Injection	SCD
92	1719291	furosemide 40 MG per 4 ML Injection	SY
93	1791721	oxytocin 10 UNT in 1 ML Injection	PSN
94	1791721	1 ML oxytocin 10 UNT/ML Injection	SCD
95	1791721	oxytocin 10 UNT per 1 ML Injection	SY
96	1791723	Pitocin 10 UNT in 1 ML Injection	PSN
97	1791723	1 ML oxytocin 10 UNT/ML Injection [Pitocin]	SBD
98	1791723	Pitocin 10 UNT per 1 ML Injection	SY
99	1795514	dextrose 50 % in 50 ML Injection	PSN
100	1795514	50 ML glucose 500 MG/ML Injection	SCD
101	1795514	dextrose 50 % per 50 ML Injection	SY
102	1807627	sodium chloride 0.9 % in 150 ML Injection	PSN
103	1807627	150 ML sodium chloride 9 MG/ML Injection	SCD
104	1807627	150 ML NaCl 9 MG/ML Injection	SY
105	1807627	sodium chloride 0.9 % per 150 ML Injection	SY
106	1807630	sodium chloride 0.9 % in 25 ML Injection	PSN
107	1807630	25 ML sodium chloride 9 MG/ML Injection	SCD
108	1807630	25 ML NaCl 9 MG/ML Injection	SY
109	1807630	sodium chloride 0.9 % per 25 ML Injection	SY
110	1807631	sodium chloride 0.9 % in 50 ML Injection	PSN
111	1807631	50 ML sodium chloride 9 MG/ML Injection	SCD
112	1807631	50 ML NaCl 9 MG/ML Injection	SY
113	1807631	sodium chloride 0.9 % per 50 ML Injection	SY
114	1807632	sodium chloride 0.9 % in 100 ML Injection	PSN
115	1807632	100 ML sodium chloride 9 MG/ML Injection	SCD
116	1807632	100 ML NaCl 9 MG/ML Injection	SY
117	1807632	sodium chloride 0.9 % per 100 ML Injection	SY
118	1807633	sodium chloride 0.9 % in 250 ML Injection	PSN
119	1807633	250 ML sodium chloride 9 MG/ML Injection	SCD
120	1807633	250 ML NaCl 9 MG/ML Injection	SY
121	1807633	sodium chloride 0.9 % per 250 ML Injection	SY
122	1807634	sodium chloride 0.9 % in 500 ML Injection	PSN
123	1807634	500 ML sodium chloride 9 MG/ML Injection	SCD
124	1807634	500 ML NaCl 9 MG/ML Injection	SY
125	1807634	sodium chloride 0.9 % per 500 ML Injection	SY
126	1807639	sodium chloride 0.9 % in 1000 ML Injection	PSN
127	1807639	1000 ML sodium chloride 9 MG/ML Injection	SCD
128	1807639	1000 ML NaCl 9 MG/ML Injection	SY
129	1807639	sodium chloride 0.9 % per 1000 ML Injection	SY
130	2123072	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir	PSN
131	2123072	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
132	2123072	albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir	SY
133	2123076	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin	PSN
134	2123076	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
135	2123076	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin	SY
136	2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN
137	2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
138	2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY

Label: MODEL AA-8565CV-ACT MODEL AA-8565CV- kit

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Label: MODEL AA-8565CV-ACT MODEL AA-8565CV- kit

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MODEL AA-8565CV-ACT MODEL AA-8565CV- kit

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MODEL AA-8565CV-ACT MODEL AA-8565CV- kit

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