Home NDC 70954-040 Fosfomycin Tromethamine
Product NDC 70954-040
11-digit product format 709540040
Labeler code 70954
Product ID 70954-040_bc26713a-907e-4277-be0e-28399f873d69
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosfomycin Tromethamine
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA210426
Marketing category ANDA
Marketing start 2026-10-01
Substance FOSFOMYCIN TROMETHAMINE
Active strength 3 g/1
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 A210426-001 FOSFOMYCIN TROMETHAMINE FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2026-08-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A210426-001 AA
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 A210426-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2026-08-12 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210426-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2026-08-12 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 A210426-001 AA 1 84e616aacf4f…2026-08-18 06:07:40 2026-07 A210426-001 AA 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 Fosfomycin Tromethamine
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FOSFOMYCIN TROMETHAMINE 3 g/1
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70954-040-10 70954004010 1 PACKET in 1 CARTON (70954-040-10) / 1 GRANULE, FOR SOLUTION in 1 PACKET 1 packet 2026-10-01 No No Current