NDC 70040-0189

APADAZ

Benzhydrocodone And Acetaminophen

APADAZ is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Kempharm, Inc.. The primary component is Benzhydrocodone Hydrochloride; Acetaminophen.

Product ID70040-0189_4e76bae1-6ed1-4624-af64-2151218705b4
NDC70040-0189
Product TypeHuman Prescription Drug
Proprietary NameAPADAZ
Generic NameBenzhydrocodone And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2019-06-28
Marketing CategoryNDA / NDA
Application NumberNDA208653
Labeler NameKemPharm, Inc.
Substance NameBENZHYDROCODONE HYDROCHLORIDE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70040-0189-1

100 TABLET in 1 BOTTLE, PLASTIC (70040-0189-1)
Marketing Start Date2019-06-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70040-0189-3 [70040018903]

APADAZ TABLET
Marketing CategoryNDA
Application NumberNDA208653
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-28
Marketing End Date2019-06-28

NDC 70040-0189-1 [70040018901]

APADAZ TABLET
Marketing CategoryNDA
Application NumberNDA208653
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-06-28
Marketing End Date2019-06-28

Drug Details

Active Ingredients

IngredientStrength
BENZHYDROCODONE HYDROCHLORIDE8.16 mg/1

OpenFDA Data

SPL SET ID:0590d4e5-7107-4015-a6a8-deac14265aa2
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2118730
  • 2118732
  • 2118734
  • 2118728
  • 2001364
  • 2001358
    • UPC Code
  • 0370040014511
  • 0370040016713
  • 0370040018915

    • NDC Crossover Matching brand name "APADAZ" or generic name "Benzhydrocodone And Acetaminophen"

    NDCBrand NameGeneric Name
    10702-340APADAZBenzhydrocodone and Acetaminophen
    10702-341APADAZBenzhydrocodone and Acetaminophen
    10702-342APADAZBenzhydrocodone and Acetaminophen
    70040-0145APADAZBenzhydrocodone and Acetaminophen
    70040-0167APADAZBenzhydrocodone and Acetaminophen
    70040-0189APADAZBenzhydrocodone and Acetaminophen
    10702-343Benzhydrocodone and AcetaminophenBenzhydrocodone and Acetaminophen
    10702-344Benzhydrocodone and AcetaminophenBenzhydrocodone and Acetaminophen
    10702-345Benzhydrocodone and AcetaminophenBenzhydrocodone and Acetaminophen

    Trademark Results [APADAZ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    APADAZ
    APADAZ
    88217342 not registered Live/Pending
    KemPharm, Inc.
    2018-12-05
    APADAZ
    APADAZ
    88217332 not registered Live/Pending
    KemPharm, Inc.
    2018-12-05
    APADAZ
    APADAZ
    88217323 not registered Live/Pending
    KemPharm, Inc.
    2018-12-05
    APADAZ
    APADAZ
    88217316 not registered Live/Pending
    KemPharm, Inc.
    2018-12-05
    APADAZ
    APADAZ
    86837825 5519982 Live/Registered
    KemPharm, Inc.
    2015-12-03
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