Home NDC 0480-2596 Fidaxomicin
Product NDC 0480-2596
11-digit product format 004802596
Labeler code 0480
Product ID 0480-2596_2b91a4ed-fd17-4794-ab84-877d8ad45f48
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 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 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# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
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
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
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