NDC 52015-080

Dificid

Fidaxomicin

Dificid is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Fidaxomicin.

• Product ID: 52015-080_14fbf752-8720-435a-b9ad-073c43db521a
• NDC: 52015-080
• Product Type: Human Prescription Drug
• Proprietary Name: Dificid
• Generic Name: Fidaxomicin
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2011-05-27
• Marketing Category: NDA / NDA
• Application Number: NDA201699
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: FIDAXOMICIN
• Active Ingredient Strength: 200 mg/1
• Pharm Classes: Macrolides [CS],Macrolide Antibacterial [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 52015-080-01

1 BOTTLE in 1 CARTON (52015-080-01) > 20 TABLET, FILM COATED in 1 BOTTLE

• Marketing Start Date: 2011-05-27
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52015-080-02 [52015008002]

Dificid TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA201699
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-05-27
• Marketing End Date: 2014-05-29

NDC 52015-080-12 [52015008012]

Dificid TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA201699
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2011-05-27
• Marketing End Date: 2014-05-29

NDC 52015-080-01 [52015008001]

Dificid TABLET, FILM COATED

• Marketing Category: NDA
• Application Number: NDA201699
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-05-27

Drug Details

Active Ingredients

Ingredient	Strength
FIDAXOMICIN	200 mg/1

OpenFDA Data

• SPL SET ID: dd966338-c820-4270-b704-09ef75fa3ceb
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • Z5N076G8YQ
• RxNorm Concept Unique ID - RxCUI:
  • 1111106
  • 1111110

Pharmacological Class

• Macrolides [CS]
• Macrolide Antibacterial [EPC]

Medicade Reported Pricing

52015008001 DIFICID 200 MG TABLET

Pricing Unit: EA | Drug Type:

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

NDC	Brand Name	Generic Name
52015-080	Dificid	fidaxomicin
52015-700	DIFICID	FIDAXOMICIN