NDC 68151-4980

XIFAXAN

Rifaximin

XIFAXAN is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Carilion Materials Management. The primary component is Rifaximin.

Product ID68151-4980_0d88990d-6f38-4813-ab36-9d859a3453d6
NDC68151-4980
Product TypeHuman Prescription Drug
Proprietary NameXIFAXAN
Generic NameRifaximin
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2004-07-25
Marketing CategoryNDA / NDA
Application NumberNDA021361
Labeler NameCarilion Materials Management
Substance NameRIFAXIMIN
Active Ingredient Strength200 mg/1
Pharm ClassesRifamycin Antibacterial [EPC],Rifamycins [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 68151-4980-0

1 TABLET in 1 PACKAGE (68151-4980-0)
Marketing Start Date2004-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68151-4980-0 [68151498000]

XIFAXAN TABLET
Marketing CategoryNDA
Application NumberNDA021361
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2004-07-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
RIFAXIMIN200 mg/1

OpenFDA Data

SPL SET ID:49df84cd-0ef6-446b-b2af-556abc665ad9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 429662
  • 539789
  • Pharmacological Class

    • Rifamycin Antibacterial [EPC]
    • Rifamycins [CS]

    NDC Crossover Matching brand name "XIFAXAN" or generic name "Rifaximin"

    NDCBrand NameGeneric Name
    50090-2445XIFAXANrifaximin
    55154-6777XIFAXANrifaximin
    65649-301XIFAXANrifaximin
    65649-303XIFAXANrifaximin
    68151-4980XIFAXANrifaximin
    68258-1107XIFAXANRIFAXIMIN
    69189-0309XIFAXANrifaximin

    Trademark Results [XIFAXAN]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    XIFAXAN
    XIFAXAN
    78428755 2965332 Live/Registered
    ALFASIGMA S.P.A.
    2004-06-02

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