fidaxomicin

Generic: fidaxomicin

Labeler: teva pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fidaxomicin
Generic Name fidaxomicin
Labeler teva pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fidaxomicin 200 mg/1

Manufacturer
Teva Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 0480-2596
Product ID 0480-2596_62052410-0ab9-4ed6-aff5-36ef8eb81850
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA208443
Listing Expiration 2026-12-31
Marketing Start 2025-07-15

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04802596
Hyphenated Format 0480-2596

Supplemental Identifiers

RxCUI
1111106
UPC
0304802596342
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 fidaxomicin (source: ndc)
Generic Name fidaxomicin (source: ndc)
Application Number ANDA208443 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)
source: ndc

Packages (1)

0480-2596-34 20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)

Ingredients (1)

fidaxomicin (200 mg/1)

Linked Drug Pages (1)

Fidaxomicin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "62052410-0ab9-4ed6-aff5-36ef8eb81850", "openfda": {"nui": ["M0028311", "N0000175431"], "upc": ["0304802596342"], "unii": ["Z5N076G8YQ"], "rxcui": ["1111106"], "spl_set_id": ["df9b6680-1ce1-41a4-b264-6330b1a14729"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_epc": ["Macrolide Antibacterial [EPC]"], "manufacturer_name": ["Teva Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34)", "package_ndc": "0480-2596-34", "marketing_start_date": "20250715"}], "brand_name": "Fidaxomicin", "product_id": "0480-2596_62052410-0ab9-4ed6-aff5-36ef8eb81850", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antibacterial [EPC]", "Macrolides [CS]"], "product_ndc": "0480-2596", "generic_name": "fidaxomicin", "labeler_name": "Teva Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fidaxomicin", "active_ingredients": [{"name": "FIDAXOMICIN", "strength": "200 mg/1"}], "application_number": "ANDA208443", "marketing_category": "ANDA", "marketing_start_date": "20250715", "listing_expiration_date": "20261231"}