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

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

Drug Label Information

Updated May 5, 2021

If you are a consumer or patient please visit this version.

  • Aerospace Accessory Service

    Aerospace Accessory Service

    P/N:

    S/N:

    EXP:

    Prep. By: 

    Label

  • 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 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
    Part 2
    Part 3
    Part 4
    Part 5
    Part 6
    Part 7
    Part 8
    Part 9
    Part 10
    Part 11
    Part 12
    Part 13
    Part 14
    Part 15
    Part 16
    Part 17
    Part 18
    Part 19
    Part 20
    Part 21
    Part 22
    Part 23
    Part 24
    Part 25
    Part 26
    Part 1 of 26
    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 26
    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 26
    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 26
    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 26
    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 26
    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 7 of 26
    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 8 of 26
    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 9 of 26
    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 10 of 26
    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 11 of 26
    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 12 of 26
    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 13 of 26
    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 14 of 26
    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 15 of 26
    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 16 of 26
    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 17 of 26
    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 18 of 26
    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 19 of 26
    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 20 of 26
    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 21 of 26
    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 22 of 26
    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 23 of 26
    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 24 of 26
    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 25 of 26
    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 26 of 26
    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