NDC 13668-577

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE

Hydrocodone Bitartrate And Homatropine Methylbromide

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Torrent Pharmaceuticals Limited. The primary component is Hydrocodone Bitartrate; Homatropine Methylbromide.

Product ID13668-577_7ffdae51-6d3f-385f-e053-2991aa0aa05c
NDC13668-577
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
Generic NameHydrocodone Bitartrate And Homatropine Methylbromide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-09-19
Marketing CategoryANDA / ANDA
Application NumberANDA204765
Labeler NameTorrent Pharmaceuticals Limited
Substance NameHYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active Ingredient Strength5 mg/5mL; mg/5mL
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 13668-577-10

473 mL in 1 BOTTLE (13668-577-10)
Marketing Start Date2018-09-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 13668-577-10 [13668057710]

HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA204765
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-09-19

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/5mL

OpenFDA Data

SPL SET ID:4ea80885-b078-4661-a057-e6ac1f3269a9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 992668
    • UPC Code
  • 0313668577105

    • Pharmacological Class

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