NDC 52015-700

DIFICID

Fidaxomicin

DIFICID is a Oral Granule, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Fidaxomicin.

Product ID52015-700_14fbf752-8720-435a-b9ad-073c43db521a
NDC52015-700
Product TypeHuman Prescription Drug
Proprietary NameDIFICID
Generic NameFidaxomicin
Dosage FormGranule, For Suspension
Route of AdministrationORAL
Marketing Start Date2020-02-18
Marketing CategoryNDA / NDA
Application NumberNDA213138
Labeler NameMerck Sharp & Dohme Corp.
Substance NameFIDAXOMICIN
Active Ingredient Strength200 mg/5mL
Pharm ClassesMacrolides [CS],Macrolide Antibacterial [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 52015-700-22

1 POUCH in 1 CARTON (52015-700-22) > 1 BOTTLE, GLASS in 1 POUCH (52015-700-23) > 150 mL in 1 BOTTLE, GLASS (52015-700-21)
Marketing Start Date2020-02-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52015-700-23 [52015070023]

DIFICID GRANULE, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA213138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18

NDC 52015-700-22 [52015070022]

DIFICID GRANULE, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA213138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18

NDC 52015-700-21 [52015070021]

DIFICID GRANULE, FOR SUSPENSION
Marketing CategoryNDA
Application NumberNDA213138
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-18

Drug Details

Active Ingredients

IngredientStrength
FIDAXOMICIN200 mg/5mL

OpenFDA Data

SPL SET ID:dd966338-c820-4270-b704-09ef75fa3ceb
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2279843
  • 2279847
  • 1111106
  • 1111110
  • Pharmacological Class

    • Macrolides [CS]
    • Macrolide Antibacterial [EPC]

    NDC Crossover Matching brand name "DIFICID" or generic name "Fidaxomicin"

    NDCBrand NameGeneric Name
    52015-080Dificidfidaxomicin
    52015-700DIFICIDFIDAXOMICIN

    Trademark Results [DIFICID]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DIFICID
    DIFICID
    77523422 4035329 Live/Registered
    MERCK SHARP & DOHME CORP.
    2008-07-16

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