Home NDC 51407-738 Trimethoprim
Product NDC 51407-738
11-digit product format 514070738
Labeler code 51407
Product ID 51407-738_f756ebc3-07b1-1291-e053-6394a90a313c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Golden State Medical Supply, Inc.
Application ANDA216393
Marketing category ANDA
Marketing start 2022-10-28
Substance TRIMETHOPRIM
Active strength 100 mg/1
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA]
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 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 A216393-001 TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216393-001 AB
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 2026-02-19 14:30 UTC 2026-02 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 3a93d1ddd44b…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216393-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2022-10-28 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Trimethoprim
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TRIMETHOPRIM 100 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination AN164J8Y0X Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198332 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 51407-738-01 Trimethoprim 100 in 1 BOTTLE, PLASTIC TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51407-738 TRIMETHOPRIM TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.] 1 Current NDC, 1 package rows 20230321_f756f4be-3cda-ab98-e053-6294a90a1424.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 Sample Exclude flag Status 51407-738-01 51407073801 100 TABLET in 1 BOTTLE, PLASTIC (51407-738-01) 100 tablet 2022-12-29 No No Current