DailyMed - MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

NHRIC Code(s): 27860-001-13
Packager: Aerospace Accessory Service, Inc
This is a repackaged label.
Source NDC Code(s): 50844-957

Category: MEDICAL DEVICE

Drug Label Information

Updated May 18, 2021

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Aerospace Accessory Service

Aerospace Accessory Service

P/N:

S/N:

EXP:

Prep. By:

INGREDIENTS AND APPEARANCE

MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)
emergency response safety kit kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:27860-001

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:27860-001-13	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 1 of 27

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 27

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 27

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 27

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 27

EPINEPHRINE
epinephrine injection

Product Information
Item Code (Source)	NDC:76329-3316
Route of Administration	INTRAVENOUS, INTRACARDIAC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	Epinephrine	0.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Sodium Bisulfite (UNII: TZX5469Z6I)
Sodium Chloride (UNII: 451W47IQ8X)
Hydrochloric Acid (UNII: QTT17582CB)
Sodium Citrate (UNII: 1Q73Q2JULR)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		12/01/1976

Part 6 of 27

EPINEPHRINE
epinephrine injection, solution

Product Information
Item Code (Source)	NDC:0409-4933
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	Epinephrine	0.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
Sodium Chloride (UNII: 451W47IQ8X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA209359	03/10/2021

Part 7 of 27

EPINEPHRINE
epinephrine injection, solution

Product Information
Item Code (Source)	NDC:0409-4921
Route of Administration	INTRAVENOUS, INTRACARDIAC, ENDOTRACHEAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	0.1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM METABISULFITE (UNII: 4VON5FNS3C)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		09/14/2005	01/01/2017

Part 8 of 27

LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride injection, solution

Product Information
Item Code (Source)	NDC:0409-1323
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg in 1 mL

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA040302	12/09/2005

Part 9 of 27

LIDOCAINE
lidocaine hydrochloride injection, solution

Product Information
Item Code (Source)	NDC:63323-208
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg in 1 mL

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA017584	09/05/2000

Part 10 of 27

LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride injection

Product Information
Item Code (Source)	NDC:76329-3390
Route of Administration	INTRAVENOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	20 mg in 1 mL

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

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA083173	06/01/2001

Part 11 of 27

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 12 of 27

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 13 of 27

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 14 of 27

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 15 of 27

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 16 of 27

EASY CARE FIRST AID DIPHENHYDRAMINE
diphenhydramine hydrochloride tablet, film coated

Product Information
Item Code (Source)	NDC:4422-0017
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Ingredient Name	Strength
Inactive Ingredients
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
D&C RED NO. 27 (UNII: 2LRS185U6K)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink (pink)	Score	no score
Shape	OVAL (OVAL)	Size	11mm
Flavor		Imprint Code	048;D
Contains

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	01/01/2012

Part 17 of 27

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 18 of 27

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 19 of 27

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 20 of 27

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 21 of 27

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 22 of 27

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 23 of 27

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 24 of 27

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 25 of 27

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 26 of 27

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 27 of 27

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

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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May 6, 2021	2	download
Jan 12, 2021	1	download

	RxCUI	RxNorm NAME	RxTTY
1	198039	nitroglycerin 0.4 MG Sublingual Tablet	PSN
2	198039	nitroglycerin 0.4 MG Sublingual Tablet	SCD
3	198039	nitroglycerin 400 MCG Sublingual Tablet	SY
4	198039	NTG 0.4 MG Sublingual Tablet	SY
5	198039	TNG 0.4 MG Sublingual Tablet	SY
6	212033	aspirin 325 MG Oral Tablet	PSN
7	212033	aspirin 325 MG Oral Tablet	SCD
8	212033	ASA 325 MG Oral Tablet	SY
9	313782	acetaminophen 325 MG Oral Tablet	PSN
10	313782	acetaminophen 325 MG Oral Tablet	SCD
11	313782	APAP 325 MG Oral Tablet	SY
12	727373	EPINEPHrine 1 MG in 10 ML Prefilled Syringe	PSN
13	727373	10 ML epinephrine 0.1 MG/ML Prefilled Syringe	SCD
14	727373	epinephrine 1 MG per 10 ML Prefilled Syringe	SY
15	727517	dextrose 50 % in 50 ML Prefilled Syringe	PSN
16	727517	50 ML glucose 500 MG/ML Prefilled Syringe	SCD
17	727517	50 ML dextrose 50 % Prefilled Syringe	SY
18	727517	dextrose 25 GM per 50 ML Prefilled Syringe	SY
19	745752	ProAir HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN
20	745752	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [ProAir]	SBD
21	745752	200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler	SY
22	745752	NDA021457 200 ACTUAT ProAir 0.09 MG/ACTUAT Metered Dose Inhaler	SY
23	745752	ProAir HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY
24	745752	ProAir HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUAT	SY
25	745752	ProAir HFA 90 MCG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY
26	797544	isopropyl alcohol 70 % Medicated Pad	PSN
27	797544	isopropyl alcohol 0.7 ML/ML Medicated Pad	SCD
28	797544	isopropyl alcohol 70 % Medicated Pad	SY
29	797544	isopropyl alcohol 70 % Topical Cloth	SY
30	797544	isopropyl alcohol 70 % Topical Swab	SY
31	801092	albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin	PSN
32	801092	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
33	801092	albuterol 0.09 MG/ACTUAT 60 ACTUAT Metered Dose Inhaler	SY
34	801092	albuterol 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY
35	801092	albuterol 90 MCG/INHAL Metered Dose Inhaler, 60 ACTUAT, generic for Ventolin	SY
36	801095	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 60 Actuations	PSN
37	801095	NDA020983 60 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD
38	801095	NDA020983 60 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler	SY
39	801095	Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY
40	801095	Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 60 ACTUAT	SY
41	801095	Ventolin HFA 90 MCG/ACTUAT (albuterol sulfate 108 MCG/ACTUAT from mouthpiece) 60 ACTUAT Metered Dose Inhaler	SY
42	859088	Ventolin HFA 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations	PSN
43	859088	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler [Ventolin]	SBD
44	859088	NDA020983 200 ACTUAT Ventolin 0.09 MG/ACTUAT Metered Dose Inhaler	SY
45	859088	Ventolin HFA 0.09 MG/ACTUAT (albuterol sulfate 0.108 MG/ACTUAT from mouthpiece) Metered Dose Inhaler, 200 ACTUAT	SY
46	859088	Ventolin HFA 0.09 MG/ACTUAT Metered Dose Inhaler, 200 ACTUAT	SY
47	1012068	lidocaine HCl 2 % in 5 ML Prefilled Syringe	PSN
48	1012068	5 ML lidocaine hydrochloride 20 MG/ML Prefilled Syringe	SCD
49	1012068	lidocaine HCl 100 MG per 5 ML Prefilled Syringe	SY
50	1012068	lidocaine HCl 2 % per 5 ML Prefilled Syringe	SY
51	1049630	diphenhydrAMINE HCl 25 MG Oral Tablet	PSN
52	1049630	diphenhydramine hydrochloride 25 MG Oral Tablet	SCD
53	1049633	diphenhydrAMINE HCl 50 MG/ML Injectable Solution	PSN
54	1049633	diphenhydramine hydrochloride 50 MG/ML Injectable Solution	SCD
55	1049633	diphenhydramine HCl 50 MG/ML Injectable Solution	SY
56	1190546	atropine sulfate 1 MG in 10 ML Prefilled Syringe	PSN
57	1190546	10 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD
58	1190546	atropine sulfate 1 MG per 10 ML Prefilled Syringe	SY
59	1190552	atropine sulfate 0.5 MG in 5 ML Prefilled Syringe	PSN
60	1190552	5 ML atropine sulfate 0.1 MG/ML Prefilled Syringe	SCD
61	1190552	atropine sulfate 0.5 MG per 5 ML Prefilled Syringe	SY
62	1190552	atropine sulfate 500 MCG per 5 ML Prefilled Syringe	SY
63	1660014	EPINEPHrine 1 MG in 1 ML Injection	PSN
64	1660014	1 ML epinephrine 1 MG/ML Injection	SCD
65	1660014	epinephrine 1 MG per 1 ML Injection	SY
66	1737761	lidocaine HCl 2 % in 5 ML Injection	PSN
67	1737761	5 ML lidocaine hydrochloride 20 MG/ML Injection	SCD
68	1737761	lidocaine HCl 100 MG per 5 ML Injection	SY
69	1737761	lidocaine HCl 2 % per 5 ML Injection	SY
70	1795514	dextrose 50 % in 50 ML Injection	PSN
71	1795514	50 ML glucose 500 MG/ML Injection	SCD
72	1795514	dextrose 50 % per 50 ML Injection	SY
73	1807627	sodium chloride 0.9 % in 150 ML Injection	PSN
74	1807627	150 ML sodium chloride 9 MG/ML Injection	SCD
75	1807627	150 ML NaCl 9 MG/ML Injection	SY
76	1807627	sodium chloride 0.9 % per 150 ML Injection	SY
77	1807630	sodium chloride 0.9 % in 25 ML Injection	PSN
78	1807630	25 ML sodium chloride 9 MG/ML Injection	SCD
79	1807630	25 ML NaCl 9 MG/ML Injection	SY
80	1807630	sodium chloride 0.9 % per 25 ML Injection	SY
81	1807631	sodium chloride 0.9 % in 50 ML Injection	PSN
82	1807631	50 ML sodium chloride 9 MG/ML Injection	SCD
83	1807631	50 ML NaCl 9 MG/ML Injection	SY
84	1807631	sodium chloride 0.9 % per 50 ML Injection	SY
85	1807632	sodium chloride 0.9 % in 100 ML Injection	PSN
86	1807632	100 ML sodium chloride 9 MG/ML Injection	SCD
87	1807632	100 ML NaCl 9 MG/ML Injection	SY
88	1807632	sodium chloride 0.9 % per 100 ML Injection	SY
89	1807633	sodium chloride 0.9 % in 250 ML Injection	PSN
90	1807633	250 ML sodium chloride 9 MG/ML Injection	SCD
91	1807633	250 ML NaCl 9 MG/ML Injection	SY
92	1807633	sodium chloride 0.9 % per 250 ML Injection	SY
93	1807634	sodium chloride 0.9 % in 500 ML Injection	PSN
94	1807634	500 ML sodium chloride 9 MG/ML Injection	SCD
95	1807634	500 ML NaCl 9 MG/ML Injection	SY
96	1807634	sodium chloride 0.9 % per 500 ML Injection	SY
97	1807639	sodium chloride 0.9 % in 1000 ML Injection	PSN
98	1807639	1000 ML sodium chloride 9 MG/ML Injection	SCD
99	1807639	1000 ML NaCl 9 MG/ML Injection	SY
100	1807639	sodium chloride 0.9 % per 1000 ML Injection	SY
101	2123072	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for ProAir	PSN
102	2123072	NDA021457 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
103	2123072	albuterol 90 MCG/ACTUAT Metered Dose Inhaler, 200 Actuations, generic for ProAir	SY
104	2123076	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin	PSN
105	2123076	NDA020983 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
106	2123076	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuation, generic for Ventolin	SY
107	2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	PSN
108	2123111	NDA020503 200 ACTUAT albuterol 0.09 MG/ACTUAT Metered Dose Inhaler	SCD
109	2123111	albuterol 90 MCG/INHAL Metered Dose Inhaler, 200 Actuations, generic for Proventil	SY

Label: MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

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Label: MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

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MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

Number of versions: 3

MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

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MODEL 2004FAA MODEL 3-EEMK MODEL 3-EEMK-1 MODEL AA-8565 MODEL AA-8565-LATAM MODEL AWFAREMK MODEL CHAUTAUQUAEMK MODEL EMK1000-10 MODEL FAREMK MODEL PMONTFAREMK MODEL SWEEMK MODEL SWEEMK-1 MODEL QXEMK MODEL G4FAREMK MODEL AA-8565 (EXCLUDING MIAMI AIR)- kit

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.