NDC 0574-1105

Hydrocodone Bitartrate and Homatropine Methylbromide

Hydrocodone Bitartrate, Homatropine Methylbromide

Hydrocodone Bitartrate and Homatropine Methylbromide is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Paddock Laboratories, Llc. The primary component is Hydrocodone Bitartrate; Homatropine Methylbromide.

Product ID0574-1105_d14e84cd-5205-4b1c-99b7-59d30b6ab09a
NDC0574-1105
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Bitartrate and Homatropine Methylbromide
Generic NameHydrocodone Bitartrate, Homatropine Methylbromide
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-06-16
Marketing End Date2019-05-31
Marketing CategoryANDA / ANDA
Application NumberANDA205731
Labeler NamePaddock Laboratories, LLC
Substance NameHYDROCODONE BITARTRATE; HOMATROPINE METHYLBROMIDE
Active Ingredient Strength5 mg/5mL; mg/5mL
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN

Packaging

NDC 0574-1105-16

473 mL in 1 BOTTLE (0574-1105-16)
Marketing Start Date2017-06-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0574-1105-16 [00574110516]

Hydrocodone Bitartrate and Homatropine Methylbromide SOLUTION
Marketing CategoryANDA
Application NumberANDA205731
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-06-16
Marketing End Date2019-05-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/5mL

OpenFDA Data

SPL SET ID:9ef47991-7cab-4840-9118-3a4c56616c1b
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, 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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