NDC 21695-774

Xodol

Hydrocodone Bitartrate And Acetaminophen

Xodol is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Hydrocodone Bitartrate; Acetaminophen.

Product ID21695-774_3d6ce551-6a0a-4d40-8592-cd6d92d55913
NDC21695-774
Product TypeHuman Prescription Drug
Proprietary NameXodol
Generic NameHydrocodone Bitartrate And Acetaminophen
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-06-23
Marketing CategoryANDA / ANDA
Application NumberANDA040556
Labeler NameRebel Distributors Corp.
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-774-30

30 TABLET in 1 BOTTLE (21695-774-30)
Marketing Start Date2004-06-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-774-72 [21695077472]

Xodol TABLET
Marketing CategoryANDA
Application NumberANDA040556
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-05-31
Inactivation Date2019-09-24

NDC 21695-774-60 [21695077460]

Xodol TABLET
Marketing CategoryANDA
Application NumberANDA040556
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-06-23
Inactivation Date2019-09-24

NDC 21695-774-30 [21695077430]

Xodol TABLET
Marketing CategoryANDA
Application NumberANDA040556
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-06-23
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE7.5 mg/1

OpenFDA Data

SPL SET ID:ddfc14c4-6f0f-4f97-b49f-d516552d3c1f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 856984
  • 856992
  • 856991
  • 856987
  • 856980
  • 856996

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    21695-773XodolXodol
    21695-775XodolXodol
    21695-774XodolXodol
    42254-301XodolXodol
    42254-291XodolXodol
    42254-114XodolXodol
    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 [Xodol]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XODOL
    XODOL
    78256758 2943009 Live/Registered
    SHIONOGI INC.
    2003-06-02
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.