NDC 43386-118

Hydrocodone Bitartrate and Homatropine Methylbromide

Hydrocodone Bitartrate And Homatropine Methylbromide

Hydrocodone Bitartrate and Homatropine Methylbromide is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Lupin Pharmaceuticals,inc.. The primary component is Hydrocodone Bitartrate; Homatropine Methylbromide.

Product ID43386-118_cc0b2769-2881-46f9-9da2-ca325419a432
NDC43386-118
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Homatropine Methylbromide
Generic NameHydrocodone Bitartrate And Homatropine Methylbromide
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-09-23
Marketing CategoryANDA / ANDA
Application NumberANDA091528
Labeler NameLupin Pharmaceuticals,Inc.
Substance NameHYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43386-118-01

100 TABLET in 1 BOTTLE (43386-118-01)
Marketing Start Date2014-09-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43386-118-03 [43386011803]

Hydrocodone Bitartrate and Homatropine Methylbromide TABLET
Marketing CategoryANDA
Application NumberANDA091528
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-23

NDC 43386-118-01 [43386011801]

Hydrocodone Bitartrate and Homatropine Methylbromide TABLET
Marketing CategoryANDA
Application NumberANDA091528
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-09-23

NDC 43386-118-05 [43386011805]

Hydrocodone Bitartrate and Homatropine Methylbromide TABLET
Marketing CategoryANDA
Application NumberANDA091528
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-23

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/1

OpenFDA Data

SPL SET ID:41ac90b3-f007-4eb2-9d41-ea626ced2017
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992656
  • UPC Code
  • 0343386118038
  • Pharmacological Class

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

    Medicade Reported Pricing

    43386011803 HYDROCODONE-HOMATROPINE 5-1.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    43386011801 HYDROCODONE-HOMATROPINE 5-1.5 MG TABLET

    Pricing Unit: EA | Drug Type:

    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.