NDC 54348-013

HYDROCODONE/APAP

Hydrocodone Bitartrate,

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 ID54348-013_47c0f6e2-91e1-42d2-9fce-c74799ac3109
NDC54348-013
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE/APAP
Generic NameHydrocodone Bitartrate,
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2014-09-01
Marketing CategoryANDA / ANDA
Application NumberANDA040099
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 54348-013-01

1 BLISTER PACK in 1 BOX (54348-013-01) > 1 TABLET in 1 BLISTER PACK
Marketing Start Date2014-09-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-013-01 [54348001301]

HYDROCODONE/APAP TABLET
Marketing CategoryANDA
Application NumberANDA040099
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-09-01
Marketing End Date2014-12-31
Inactivation Date2020-01-31
Reactivation Date2020-02-11

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/1

OpenFDA Data

SPL SET ID:dcac1bee-8f12-4c84-b5cb-fa3407205283
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856903

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    54348-013HYDROCODONE/APAPHYDROCODONE BITARTRATE,
    54348-066HYDROCODONE/APAPHYDROCODONE BITARTRATE, ACETAMINOPHEN
    72189-399NorcoHydrocodone/APAP
    72189-406NorcoHYDROCODONE/APAP
    72189-407NorcoHydrocodone/APAP
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