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

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

Drug Label Information

Updated May 5, 2021

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  • INGREDIENTS AND APPEARANCE
    MODEL AA-8565CV-ACT MODEL AA-8565CV 
    emergency response safety kit kit
    Product Information
    Product TypeMEDICAL DEVICEItem Code (Source)NHRIC:27860-013
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:27860-013-161 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 27
    Part 28
    Part 1 of 28
    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 28
    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 28
    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 28
    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 28
    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 6 of 28
    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 7 of 28
    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 8 of 28
    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 9 of 28
    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 10 of 28
    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 11 of 28
    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 12 of 28
    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 13 of 28
    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 14 of 28
    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 15 of 28
    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 16 of 28
    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 17 of 28
    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 18 of 28
    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 19 of 28
    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 20 of 28
    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
    Part 21 of 28
    POVIDONE-IODINE 
    povidone-iodine solution
    Product Information
    Item Code (Source)NDC:46414-7777
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    NONOXYNOL-9 (UNII: 48Q180SH9T)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A02/14/1976
    Part 22 of 28
    BZK PADS 
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:67777-245
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  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 finalpart333A04/05/2011
    Part 23 of 28
    SOLU-CORTEF 
    hydrocortisone sodium succinate injection, powder, for solution
    Product Information
    Item Code (Source)NDC:0009-0825
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE100 mg  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA00986604/27/1955
    Part 24 of 28
    SOLU-CORTEF 
    hydrocortisone sodium succinate injection, powder, for solution
    Product Information
    Item Code (Source)NDC:0009-0011
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYDROCORTISONE SODIUM SUCCINATE (UNII: 50LQB69S1Z) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE100 mg  in 2 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)  
    SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM (UNII: GR686LBA74)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA00986604/27/1955
    Part 25 of 28
    FUROSEMIDE 
    furosemide injection, solution
    Product Information
    Item Code (Source)NDC:23155-473
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    FUROSEMIDE (UNII: 7LXU5N7ZO5) (FUROSEMIDE - UNII:7LXU5N7ZO5) FUROSEMIDE10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYDROCHLORIC ACID (UNII: QTT17582CB)  
    WATER (UNII: 059QF0KO0R)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20342809/02/2014
    Part 26 of 28
    PITOCIN 
    oxytocin injection
    Product Information
    Item Code (Source)NDC:42023-116
    Route of AdministrationINTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYTOCIN (UNII: 1JQS135EYN) (OXYTOCIN - UNII:1JQS135EYN) OXYTOCIN10 [iU]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA01826102/01/2008
    Part 27 of 28
    PROMETHAZINE HYDROCHLORIDE 
    promethazine hydrochloride injection
    Product Information
    Item Code (Source)NDC:0641-1495
    Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PROMETHAZINE HYDROCHLORIDE (UNII: R61ZEH7I1I) (PROMETHAZINE - UNII:FF28EJQ494) PROMETHAZINE HYDROCHLORIDE25 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA08331209/19/1973
    Part 28 of 28
    METOPROLOL TARTRATE 
    metoprolol tartrate tablet, film coated
    Product Information
    Item Code (Source)NDC:65862-062
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METOPROLOL TARTRATE (UNII: W5S57Y3A5L) (METOPROLOL - UNII:GEB06NHM23) METOPROLOL TARTRATE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorwhiteScore2 pieces
    ShapeROUNDSize7mm
    FlavorImprint Code C;73
    Contains    
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07773909/11/2007
    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