Home NDC 0480-2596 Fidaxomicin
Product NDC 0480-2596
11-digit product format 004802596
Labeler code 0480
Product ID 0480-2596_62052410-0ab9-4ed6-aff5-36ef8eb81850
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fidaxomicin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Teva Pharmaceuticals, Inc.
Application ANDA208443
Marketing category ANDA
Marketing start 2025-07-15
Substance FIDAXOMICIN
Active strength 200 mg/1
Pharmacologic classes Macrolide Antibacterial [EPC], Macrolides [CS]
NDC exclude flag No
Listing certified through 2026-12-31
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 A208443-001 FIDAXOMICIN FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208443-001 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 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL 2024-01-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 1c564ffb4f44…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A208443-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2024-01-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fidaxomicin
Listing expiration 2026-12-31 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 0480-2596-34 Fidaxomicin 20 in 1 BOTTLE TABLET, FILM COATED 20 3
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 Marketing start Sample Exclude flag Status 0480-2596-34 00480259634 20 TABLET, FILM COATED in 1 BOTTLE (0480-2596-34) 2025-07-15 No No Current