Home NDC 50090-5826 FOSFOMYCIN TROMETHAMINE
Product NDC 50090-5826
11-digit product format 500905826
Labeler code 50090
Product ID 50090-5826_82bcf84a-7f49-423c-a1ec-17befb33993d
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Granules for Oral
Dosage form POWDER
Route ORAL
Labeler A-S Medication Solutions
Application ANDA212548
Marketing category ANDA
Marketing start 2020-10-06
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 A212548-001 FOSFOMYCIN TROMETHAMINE FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212548-001 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 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 c0c555d07b60…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA 2020-10-06 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212548-001 FOSFOMYCIN TROMETHAMINE EQ 3GM BASE/PACKET FOR SOLUTION / ORAL AA RS 2020-10-06 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A212548-001 CGT 2021-04-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212548-001 CGT 2021-04-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A212548-001 CGT 2021-04-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A212548-001 CGT 2021-04-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A212548-001 CGT 2021-04-04 c0c555d07b60…
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# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50090-5826-0 FOSFOMYCIN TROMETHAMINE 1 in 1 DOSE PACK POWDER 1 5 50090-5826-0 FOSFOMYCIN TROMETHAMINE 1 in 1 CARTON POWDER 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5826 FOSFOMYCIN TROMETHAMINE (GRANULES FOR ORAL) POWDER [A-S MEDICATION SOLUTIONS] 5 Current NDC, Legacy NDC, 2 package rows 20231125_99becde1-fca5-4d82-8c3e-36ded62fc0d1.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5826-0 50090582600 1 DOSE PACK in 1 CARTON (50090-5826-0) / 1 POWDER in 1 DOSE PACK 1 dose pack 2021-10-26 0000-00-00 No No Current