NDC 17856-0043

Hydrocodone Bitartrate and Homatropine Methylbromide

Hydrocodone Bitartrate And Homatropine Methylbromide

Hydrocodone Bitartrate and Homatropine Methylbromide is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Hydrocodone Bitartrate; Homatropine Methylbromide.

Product ID17856-0043_19078c90-5ea1-4bcf-bc45-48a98be6f698
NDC17856-0043
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Homatropine Methylbromide
Generic NameHydrocodone Bitartrate And Homatropine Methylbromide
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2008-02-08
Marketing CategoryANDA / ANDA
Application NumberANDA040613
Labeler NameAtlantic Biologicals Corps
Substance NameHYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active Ingredient Strength5 mg/5mL; mg/5mL
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0043-1

5 mL in 1 CUP, UNIT-DOSE (17856-0043-1)
Marketing Start Date2016-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0043-1 [17856004301]

Hydrocodone Bitartrate and Homatropine Methylbromide SYRUP
Marketing CategoryANDA
Application NumberANDA040613
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-04-01
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/5mL

OpenFDA Data

SPL SET ID:0f06291e-6329-4eb0-8cb7-80a14111d480
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992668
  • Pharmacological Class

    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]

    NDC Crossover Matching brand name "Hydrocodone Bitartrate and Homatropine Methylbromide" or generic name "Hydrocodone Bitartrate And Homatropine Methylbromide"

    NDCBrand NameGeneric Name
    0121-4811Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    0574-1105Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone bitartrate, homatropine methylbromide
    10702-055Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    10702-150Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromide oral solution
    13668-577HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
    17856-0043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    17856-0455Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromide
    21695-869Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    40032-118Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    40032-810Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    43386-118Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    50383-043Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    59741-262HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDEHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
    60432-455Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromide
    60687-278Hydrocodone Bitartrate and Homatropine Methylbromidehydrocodone bitartrate and homatropine methylbromide
    64950-206Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    64950-371Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    66336-871Hydrocodone Bitartrate and Homatropine MethylbromideHydrocodone Bitartrate and Homatropine Methylbromide
    64950-205HycodanHydrocodone Bitartrate and Homatropine Methylbromide
    64950-342HycodanHydrocodone Bitartrate and Homatropine Methylbromide
    0472-1030Hydromethydrocodone bitartrate and homatropine methylbromide

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