Home NDC 60505-4833 Fidaxomicin
Product NDC 60505-4833
11-digit product format 605054833
Labeler code 60505
Product ID 60505-4833_a9a2681d-631b-f559-de45-a06b3723e65c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fidaxomicin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Apotex Corp.
Application ANDA219559
Marketing category ANDA
Marketing start 2026-02-03
Substance FIDAXOMICIN
Active strength 200 mg/1
Pharmacologic classes Macrolide Antibacterial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A219559-001 FIDAXOMICIN FIDAXOMICIN 200MG TABLET / ORAL AB 2026-02-02
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219559-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A219559-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2026-02-02 84e616aacf4f…2026-08-18 06:07:40 2026-07 A219559-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2026-02-02 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A219559-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2026-02-02 011fe1cb6892…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A219559-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2026-02-02 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fidaxomicin
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FIDAXOMICIN 200 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z5N076G8YQ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1111106 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-4833-2 Fidaxomicin 1 in 1 CARTON TABLET, FILM COATED 1 2 60505-4833-2 Fidaxomicin 20 in 1 BOTTLE TABLET, FILM COATED 20 2
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 60505-4833-2 60505483302 1 BOTTLE in 1 CARTON (60505-4833-2) / 20 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2026-02-03 No No Current