Home NDC 73289-0067 Fosfomycin Tromethamine
Product NDC 73289-0067
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 2026-07-26 02:55 UTC · 3 captures of this ZIP 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 2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217772-001 AA 1 a50c72e98297…
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
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units 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 73289-0067-2 73289006702 1 DOSE PACK in 1 CARTON (73289-0067-2) / 1 GRANULE, FOR SOLUTION in 1 DOSE PACK 1 dose pack 2026-04-09 No No Current