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   
Aerospace Accessory Service, Inc

----------

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)

Aerospace Accessory Service

Aerospace Accessory Service

P/N:

S/N:

EXP:

Prep. By: 

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) 
emergency response safety kit kit
Product Information
Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:27860-001
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:27860-001-131 in 1 PACKAGE; Type 1: Convenience Kit of Co-Package
Quantity of Parts
Part #Package QuantityTotal Product Quantity
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 AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE9 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01667712/09/1970
Part 2 of 27
SODIUM CHLORIDE 
sodium chloride injection, solution
Product Information
Item Code (Source)NDC:0264-7800
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE0.9 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01963503/09/1988
Part 3 of 27
ATROPINE SULFATE 
atropine sulfate injection, solution
Product Information
Item Code (Source)NDC:0409-4910
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, ENDOTRACHEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ATROPINE SULFATE (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) ATROPINE SULFATE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SULFURIC ACID (UNII: O40UQP6WCF)  
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02114601/19/2006
Part 4 of 27
ATROPINE SULFATE 
atropine sulfate injection
Product Information
Item Code (Source)NDC:76329-3339
Route of AdministrationPARENTERAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Atropine Sulfate (UNII: 03J5ZE7KA5) (ATROPINE - UNII:7C0697DR9I) Atropine Sulfate0.1 mg  in 1 mL
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2000
Part 5 of 27
EPINEPHRINE 
epinephrine injection
Product Information
Item Code (Source)NDC:76329-3316
Route of AdministrationINTRAVENOUS, INTRACARDIAC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) Epinephrine0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Bisulfite (UNII: TZX5469Z6I)  
Sodium Chloride (UNII: 451W47IQ8X)  
Hydrochloric Acid (UNII: QTT17582CB)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other12/01/1976
Part 6 of 27
EPINEPHRINE 
epinephrine injection, solution
Product Information
Item Code (Source)NDC:0409-4933
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) Epinephrine0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride (UNII: 451W47IQ8X)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20935903/10/2021
Part 7 of 27
EPINEPHRINE 
epinephrine injection, solution
Product Information
Item Code (Source)NDC:0409-4921
Route of AdministrationINTRAVENOUS, INTRACARDIAC, ENDOTRACHEAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) EPINEPHRINE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/14/200501/01/2017
Part 8 of 27
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride injection, solution
Product Information
Item Code (Source)NDC:0409-1323
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04030212/09/2005
Part 9 of 27
LIDOCAINE 
lidocaine hydrochloride injection, solution
Product Information
Item Code (Source)NDC:63323-208
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01758409/05/2000
Part 10 of 27
LIDOCAINE HYDROCHLORIDE 
lidocaine hydrochloride injection
Product Information
Item Code (Source)NDC:76329-3390
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE HYDROCHLORIDE (UNII: V13007Z41A) (LIDOCAINE - UNII:98PI200987) LIDOCAINE HYDROCHLORIDE ANHYDROUS20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
HYDROCHLORIC ACID (UNII: QTT17582CB)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08317306/01/2001
Part 11 of 27
DEXTROSE MONOHYDRATE 
dextrose monohydrate injection
Product Information
Item Code (Source)NDC:76329-3301
Route of AdministrationPARENTERAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE500 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/01/2000
Part 12 of 27
DEXTROSE 
dextrose monohydrate injection, solution
Product Information
Item Code (Source)NDC:0409-6648
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DEXTROSE MONOHYDRATE (UNII: LX22YL083G) (ANHYDROUS DEXTROSE - UNII:5SL0G7R0OK) DEXTROSE MONOHYDRATE25 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01944512/02/2005
Part 13 of 27
NITROGLYCERIN 
nitroglycerin tablet
Product Information
Item Code (Source)NDC:68462-639
Route of AdministrationSUBLINGUAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3) NITROGLYCERIN0.4 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM STEARATE (UNII: 776XM7047L)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
SILICA DIMETHYL SILYLATE (UNII: EU2PSP0G0W)  
Product Characteristics
Colorwhite (white to off white) Scoreno score
ShapeROUND (Flat faced) Size4mm
FlavorImprint Code 2;C
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20639108/19/2017
Part 14 of 27
DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride injection
Product Information
Item Code (Source)NDC:0641-0376
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
HYDROCHLORIC ACID (UNII: QTT17582CB)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA08081711/27/1972
Part 15 of 27
EPINEPHRINE 
epinephrine injection, solution, concentrate
Product Information
Item Code (Source)NDC:54288-103
Route of AdministrationINTRAVENOUS
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Epinephrine (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH) Epinephrine1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Sodium Chloride (UNII: 451W47IQ8X)  
Hydrochloric Acid (UNII: QTT17582CB)  
Water (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20502908/08/2014
Part 16 of 27
EASY CARE FIRST AID DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, film coated
Product Information
Item Code (Source)NDC:4422-0017
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (pink) Scoreno score
ShapeOVAL (OVAL) Size11mm
FlavorImprint Code 048;D
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34101/01/2012
Part 17 of 27
ALCOHOL PREP 
isopropyl alcohol swab
Product Information
Item Code (Source)NDC:67777-121
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.7 mL  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/01/2010
Part 18 of 27
MOORE MEDICAL NON ASPIRIN 
acetaminophen tablet, film coated
Product Information
Item Code (Source)NDC:55670-467
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN325 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code AZ;234
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34312/30/2008
Part 19 of 27
ASPIRIN 
aspirin tablet, film coated
Product Information
Item Code (Source)NDC:55670-131
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (white) Scoreno score
ShapeROUND (ROUND) Size10mm
FlavorImprint Code TCL;011
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34312/30/200808/31/2022
Part 20 of 27
MOOREBRAND ASPIRIN 
aspirin tablet, film coated
Product Information
Item Code (Source)NDC:55670-616(NDC:50844-957)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
Product Characteristics
ColorwhiteScoreno score
ShapeROUNDSize10mm
FlavorImprint Code Aspirin;44;157
Contains    
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34310/05/2020
Part 21 of 27
VENTOLIN  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC:0173-0682
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02098306/09/2006
Part 22 of 27
ALBUTEROL SULFATE  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC:66993-019
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02098301/15/2019
Part 23 of 27
ALBUTEROL SULFATE 
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC:45802-088
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
NORFLURANE (UNII: DH9E53K1Y8)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20376002/26/2020
Part 24 of 27
ALBUTEROL SULFATE  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC:0093-3174
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
ALCOHOL (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02145701/16/2019
Part 25 of 27
ALBUTEROL SULFATE 
albuterol sulfate inhalant
Product Information
Item Code (Source)NDC:69097-142
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL108 ug
Inactive Ingredients
Ingredient NameStrength
OLEIC ACID (UNII: 2UMI9U37CP)  
NORFLURANE (UNII: DH9E53K1Y8)  
ALCOHOL (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20995904/08/2020
Part 26 of 27
ALBUTEROL SULFATE 
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC:0254-1007
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL108 ug
Inactive Ingredients
Ingredient NameStrength
OLEIC ACID (UNII: 2UMI9U37CP)  
NORFLURANE (UNII: DH9E53K1Y8)  
ALCOHOL (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDA authorized genericNDA02050304/03/2019
Part 27 of 27
PROAIR  HFA
albuterol sulfate aerosol, metered
Product Information
Item Code (Source)NDC:59310-579
Route of AdministrationRESPIRATORY (INHALATION)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E) ALBUTEROL90 ug
Inactive Ingredients
Ingredient NameStrength
NORFLURANE (UNII: DH9E53K1Y8)  
ALCOHOL (UNII: 3K9958V90M)  
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02145712/03/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
exempt deviceABC01/01/2015
Labeler - Aerospace Accessory Service, Inc (859100547)
Registrant - Aerospace Accessory Service, Inc (859100547)
Establishment
NameAddressID/FEIBusiness Operations
Aerospace Accessory Service, Inc859100547manufacture, repack

Revised: 5/2021
Document Id: ad09a7e9-5490-4882-bf00-55cfdb52e81a
Set id: 9ef8edbd-047a-40fe-a603-d71fce8ada68
Version: 3
Effective Time: 20210518
 
Aerospace Accessory Service, Inc