Home NDC 0054-0795-07 Fidaxomicin
Product NDC 0054-0795
Requested package NDC 0054-0795-07
11-digit product format 000540795
Labeler code 0054
Product ID 0054-0795_77be719d-9937-40ab-a73a-b0db15398280
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fidaxomicin
Dosage form TABLET, COATED
Route ORAL
Labeler Hikma Pharmceuticals USA Inc.
Application ANDA219737
Marketing category ANDA
Marketing start 2026-10-07
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 44 .
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 A219737-001 FIDAXOMICIN FIDAXOMICIN 200MG TABLET / ORAL AB 2026-10-07
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A219737-001 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 2026-10-15 13:18:30 2026-09 A219737-001 FIDAXOMICIN 200MG TABLET / ORAL AB 2026-10-07 c2088c7a36db…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-10-15 13:18:30 2026-09 A219737-001 AB 1 c2088c7a36db…
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0054-0795-07 00054079507 20 TABLET, COATED in 1 BOTTLE (0054-0795-07) 2026-10-07 No No Current