fidaxomicin

Generic: fidaxomicin

Labeler: torrent pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name fidaxomicin
Generic Name fidaxomicin
Labeler torrent pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

fidaxomicin 200 mg/1

Manufacturer
Torrent Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 13668-745
Product ID 13668-745_e3cdb249-59e3-41f4-a3c5-efb387ec6d85
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA220374
Listing Expiration 2027-12-31
Marketing Start 2026-01-27

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 13668745
Hyphenated Format 13668-745

Supplemental Identifiers

RxCUI
1111106
UPC
0313668745214
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 ANDA220374 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/1
source: ndc
Packaging
  • 20 TABLET, FILM COATED in 1 BOTTLE (13668-745-21)
source: ndc

Packages (1)

13668-745-21 20 TABLET, FILM COATED in 1 BOTTLE (13668-745-21)

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": "e3cdb249-59e3-41f4-a3c5-efb387ec6d85", "openfda": {"nui": ["M0028311", "N0000175431"], "upc": ["0313668745214"], "unii": ["Z5N076G8YQ"], "rxcui": ["1111106"], "spl_set_id": ["8f68f0cb-9573-4d5a-8f31-a93dd2706691"], "pharm_class_cs": ["Macrolides [CS]"], "pharm_class_epc": ["Macrolide Antibacterial [EPC]"], "manufacturer_name": ["Torrent Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "20 TABLET, FILM COATED in 1 BOTTLE (13668-745-21)", "package_ndc": "13668-745-21", "marketing_start_date": "20260127"}], "brand_name": "Fidaxomicin", "product_id": "13668-745_e3cdb249-59e3-41f4-a3c5-efb387ec6d85", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Macrolide Antibacterial [EPC]", "Macrolides [CS]"], "product_ndc": "13668-745", "generic_name": "Fidaxomicin", "labeler_name": "Torrent Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Fidaxomicin", "active_ingredients": [{"name": "FIDAXOMICIN", "strength": "200 mg/1"}], "application_number": "ANDA220374", "marketing_category": "ANDA", "marketing_start_date": "20260127", "listing_expiration_date": "20271231"}