NDC 0486-4771

Zamicet

Hydrocodone Bitartrate And Acetaminophen

Zamicet is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Pharmaceutical Associates, Inc.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID0486-4771_0a8d376c-6ccd-4f17-a291-46d367d8db83
NDC0486-4771
Product TypeHuman Prescription Drug
Proprietary NameZamicet
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-03-18
Marketing CategoryANDA / ANDA
Application NumberANDA040834
Labeler NamePharmaceutical Associates, Inc.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength5 mg/7.5mL; mg/7.5mL
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 0486-4771-15

4 TRAY in 1 CASE (0486-4771-15) > 10 CUP, UNIT-DOSE in 1 TRAY > 15 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2015-03-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0486-4771-15 [00486477115]

Zamicet SOLUTION
Marketing CategoryANDA
Application NumberANDA040834
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-18
Inactivation Date2020-01-31

NDC 0486-4771-07 [00486477107]

Zamicet SOLUTION
Marketing CategoryANDA
Application NumberANDA040834
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-18
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/7.5mL

OpenFDA Data

SPL SET ID:43c30b52-7bfb-4d0f-abcf-465c919a10bf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856944
  • 856946

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Zamicet" or generic name "Hydrocodone Bitartrate And Acetaminophen"

    NDCBrand NameGeneric Name
    0121-1542ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-2313ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0486-0771ZamicetZamicet
    0486-4771ZamicetZamicet
    0121-0772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-1544Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-2316Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-4772Hydrocodone Bitartrate and AcetaminophenHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0245-0410Hydrocodone Bitartrate and AcetaminophenHydrocodone Bitartrate and Acetaminophen
    0023-6002NorcoHydrocodone Bitartrate and Acetaminophen
    0023-6021NorcoHydrocodone Bitartrate and Acetaminophen
    0023-6022NorcoHydrocodone Bitartrate and Acetaminophen
    0074-3041VicodinHydrocodone Bitartrate and Acetaminophen
    0074-3043VicodinHydrocodone Bitartrate and Acetaminophen
    0074-3054VicodinHydrocodone Bitartrate and Acetaminophen

    Trademark Results [Zamicet]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZAMICET
    ZAMICET
    86837568 5002805 Live/Registered
    Beach Products, Inc.
    2015-12-02
    ZAMICET
    ZAMICET
    77763249 3751655 Live/Registered
    BEACH PRODUCTS, INC.
    2009-06-18
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.