NDC 54348-066

HYDROCODONE/APAP

Hydrocodone Bitartrate, Acetaminophen

HYDROCODONE/APAP is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pharmpak, Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID54348-066_d0bab4bf-d2a1-4a7a-9141-3b9a7ffc9975
NDC54348-066
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE/APAP
Generic NameHydrocodone Bitartrate, Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA040736
Labeler NamePharmPak, Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength5 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 54348-066-10

10 TABLET in 1 BOTTLE (54348-066-10)
Marketing Start Date2014-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-066-10 [54348006610]

HYDROCODONE/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040736
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-01
Inactivation Date2020-01-31

NDC 54348-066-01 [54348006601]

HYDROCODONE/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040736
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-01-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/1

OpenFDA Data

SPL SET ID:fcff467e-ddcb-48d1-ac8b-a8e4435eebb2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 857002

    • Pharmacological Class

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

    NDC Crossover Matching brand name "HYDROCODONE/APAP" or generic name "Hydrocodone Bitartrate, Acetaminophen"

    NDCBrand NameGeneric Name
    54348-013HYDROCODONE/APAPHYDROCODONE BITARTRATE,
    54348-066HYDROCODONE/APAPHYDROCODONE BITARTRATE, ACETAMINOPHEN
    33261-881Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    42254-300Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    63629-5428Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    76519-1011Hydrocodone Bitartate and AcetaminophenHYDROCODONE BITARTRATE, ACETAMINOPHEN
    17856-0640Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate, Acetaminophen
    64376-640Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate, Acetaminophen
    72189-399NorcoHydrocodone/APAP
    72189-406NorcoHYDROCODONE/APAP
    72189-407NorcoHydrocodone/APAP
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