fidaxomicin

Generic: fidaxomicin

Labeler: apotex corp.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fidaxomicin
Generic Name fidaxomicin
Labeler apotex corp.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fidaxomicin 200 mg/1

Manufacturer
Apotex Corp.

Identifiers & Regulatory

Product NDC 60505-4833
Product ID 60505-4833_a9a2681d-631b-f559-de45-a06b3723e65c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA219559
Listing Expiration 2027-12-31
Marketing Start 2026-02-03

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 605054833
Hyphenated Format 60505-4833

Supplemental Identifiers

RxCUI
1111106
UPC
0360505483327
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 ANDA219559 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

60505-4833-2 1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLE

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": "a9a2681d-631b-f559-de45-a06b3723e65c", "openfda": {"nui": ["M0028311", "N0000175431"], "upc": ["0360505483327"], "unii": ["Z5N076G8YQ"], "rxcui": ["1111106"], "spl_set_id": ["6cc3e803-8935-f9b3-ab7f-fef8b1c02070"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_epc": ["Macrolide Antibacterial [EPC]"], "manufacturer_name": ["Apotex Corp."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (60505-4833-2)  / 20 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "60505-4833-2", "marketing_start_date": "20260203"}], "brand_name": "Fidaxomicin", "product_id": "60505-4833_a9a2681d-631b-f559-de45-a06b3723e65c", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antibacterial [EPC]", "Macrolides [CS]"], "product_ndc": "60505-4833", "generic_name": "Fidaxomicin", "labeler_name": "Apotex Corp.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fidaxomicin", "active_ingredients": [{"name": "FIDAXOMICIN", "strength": "200 mg/1"}], "application_number": "ANDA219559", "marketing_category": "ANDA", "marketing_start_date": "20260203", "listing_expiration_date": "20271231"}