dificid

Generic: fidaxomicin

Labeler: merck sharp & dohme llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name dificid
Generic Name fidaxomicin
Labeler merck sharp & dohme llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fidaxomicin 200 mg/1

Manufacturer
Merck Sharp & Dohme LLC

Identifiers & Regulatory

Product NDC 52015-080
Product ID 52015-080_21c95e9f-0a3d-4fb8-90b5-934bad817d00
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA201699
Listing Expiration 2026-12-31
Marketing Start 2011-05-27

Pharmacologic Class

Established (EPC)
macrolide antibacterial [epc]
Chemical Structure
macrolides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52015080
Hyphenated Format 52015-080

Supplemental Identifiers

RxCUI
1111106 1111110 2279843 2279847
UNII
Z5N076G8YQ
NUI
M0028311 N0000175431

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name dificid (source: ndc)
Generic Name fidaxomicin (source: ndc)
Application Number NDA201699 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (52015-080-01) / 20 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

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

Ingredients (1)

fidaxomicin (200 mg/1)

Linked Drug Pages (1)

Dificid, DIFICID ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21c95e9f-0a3d-4fb8-90b5-934bad817d00", "openfda": {"nui": ["M0028311", "N0000175431"], "unii": ["Z5N076G8YQ"], "rxcui": ["1111106", "1111110", "2279843", "2279847"], "spl_set_id": ["dd966338-c820-4270-b704-09ef75fa3ceb"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_epc": ["Macrolide Antibacterial [EPC]"], "manufacturer_name": ["Merck Sharp & Dohme LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (52015-080-01)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "52015-080-01", "marketing_start_date": "20110527"}], "brand_name": "Dificid", "product_id": "52015-080_21c95e9f-0a3d-4fb8-90b5-934bad817d00", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antibacterial [EPC]", "Macrolides [CS]"], "product_ndc": "52015-080", "generic_name": "fidaxomicin", "labeler_name": "Merck Sharp & Dohme LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Dificid", "active_ingredients": [{"name": "FIDAXOMICIN", "strength": "200 mg/1"}], "application_number": "NDA201699", "marketing_category": "NDA", "marketing_start_date": "20110527", "listing_expiration_date": "20261231"}