Home NDC 0781-5194 Fidaxomicin
Product NDC 0781-5194
11-digit product format 007815194
Labeler code 0781
Product ID 0781-5194_5e8ad2f1-a227-4171-9b66-cd6ce49b8baa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fidaxomicin
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Sandoz Inc
Application ANDA220465
Marketing category ANDA
Marketing start 2026-08-27
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 A220465-001 FIDAXOMICIN FIDAXOMICIN 200MG TABLET / ORAL AB 2026-08-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A220465-001 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 A220465-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2026-08-13 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220465-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2026-08-13 caaa826d4ba7…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-09-14 22:38:34 2026-08 A220465-001 AB 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A220465-001 AB 1 caaa826d4ba7…
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
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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0781-5194-20 00781519420 20 TABLET, FILM COATED in 1 BOTTLE (0781-5194-20) 2026-08-27 No No Current