NDC 17856-0450

Lortab

Hydrocodone Bitartrate And Acetaminophen

Lortab is a Oral Syrup in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID17856-0450_d6b9770a-ae60-43d7-a611-ab627652d970
NDC17856-0450
Product TypeHuman Prescription Drug
Proprietary NameLortab
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSyrup
Route of AdministrationORAL
Marketing Start Date2015-03-17
Marketing CategoryANDA / ANDA
Application NumberANDA040881
Labeler NameAtlantic Biologicals Corps
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength10 mg/15mL; mg/15mL
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0450-1

15 mL in 1 CUP, UNIT-DOSE (17856-0450-1)
Marketing Start Date2016-06-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0450-1 [17856045001]

Lortab SYRUP
Marketing CategoryANDA
Application NumberANDA040881
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2016-06-29
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/15mL

OpenFDA Data

SPL SET ID:34fddb2d-ccc5-4189-ac2a-146b46c447f6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1442445
  • 1044427

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    17856-0450LortabLortab
    17478-450LortabLortab
    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
    0121-1542ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHEN
    0121-2313ZamicetHYDROCODONE BITARTRATE and ACETAMINOPHEN

    Trademark Results [Lortab]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    LORTAB
    LORTAB
    86000274 4606812 Live/Registered
    UCB Inc.
    2013-07-02
    LORTAB
    LORTAB
    73403056 1278615 Live/Registered
    Russ Pharmaceuticals, Inc.
    1982-11-18
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