Home NDC 60219-3955 Fosfomycin Tromethamine
Product NDC 60219-3955
11-digit product format 602193955
Labeler code 60219
Product ID 60219-3955_5fd9aeff-694c-48be-93de-a2ba381ea436
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Fosfomycin Tromethamine
Dosage form GRANULE, FOR SOLUTION
Route ORAL
Labeler Amneal Pharmaceuticals NY LLC
Application ANDA216600
Marketing category ANDA
Marketing start 2024-04-02
Substance FOSFOMYCIN TROMETHAMINE
Active strength 3 g/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A216600-001 FOSFOMYCIN TROMETHAMINE FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216600-001 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 2026-08-18 06:07:40 2026-07 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 8072bd15b7f6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216600-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2024-03-25 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fosfomycin Tromethamine
Listing expiration 2026-12-31 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 60219-3955-1 Fosfomycin Tromethamine 1 in 1 CARTON GRANULE, FOR SOLUTION 1 4 60219-3955-3 Fosfomycin Tromethamine 1 in 1 PACKET GRANULE, FOR SOLUTION 1 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60219-3955 FOSFOMYCIN TROMETHAMINE GRANULE, FOR SOLUTION [AMNEAL PHARMACEUTICALS NY LLC] 4 Current NDC, 2 package rows 20240403_aacd04a4-f2d5-45a2-b9e7-0e92244a5880.zip
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 60219-3955-1 60219395501 1 PACKET in 1 CARTON (60219-3955-1) / 1 GRANULE, FOR SOLUTION in 1 PACKET (60219-3955-3) 1 packet 2024-04-02 No No Current 60219-3955-3 60219395503 1 in 1 PACKET Historical