Home NDC 73289-0067-1 Fosfomycin Tromethamine
Product NDC 73289-0067
Requested package NDC 73289-0067-1
11-digit product format 732890067
Labeler code 73289
Product ID 73289-0067_4f2091cd-2ce0-cc4e-e063-6294a90a3bbb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosfomycin tromethamine
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Aucta Pharmaceuticals, Inc.
Application ANDA217772
Marketing category ANDA
Marketing start 2026-04-09
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 1 .
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 A217772-001 FOSFOMYCIN TROMETHAMINE FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2026-04-09
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217772-001 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 2026-08-01 22:54:32 2026-06 A217772-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2026-04-09 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A217772-001 AA 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7FXW6U30GY Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 808917 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 73289-0067-1 Fosfomycin Tromethamine 1 in 1 PACKET GRANULE, FOR SOLUTION 1 1 73289-0067-2 Fosfomycin Tromethamine 1 in 1 DOSE PACK GRANULE, FOR SOLUTION 1 1 73289-0067-2 Fosfomycin Tromethamine 1 in 1 CARTON GRANULE, FOR SOLUTION 1 1
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 73289-0067-1 73289006701 1 GRANULE, FOR SOLUTION in 1 PACKET (73289-0067-1) 2026-04-09 No No Current