Home NDC 51862-486 Trimethoprim
Product NDC 51862-486
11-digit product format 518620486
Labeler code 51862
Product ID 51862-486_f26c56ff-9afc-47cc-a94a-974bf8f5039f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Mayne Pharma
Application NDA018679
Marketing category NDA
Marketing start 2016-07-18
Marketing end 0000-00-00
Substance TRIMETHOPRIM
Active strength 100 mg/1
Pharmacologic classes Dihydrofolate Reductase Inhibitor Antibacterial [EPC],Dihydrofolate Reductase Inhibitors [MoA],Cytochrome P450 2C8 Inhibitors [MoA],Organic Cation Transporter 2 Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record 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 N018679-001 TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N018679-001 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.
Product history page 1 of 2 · 41 observed 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 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N018679-001 TRIMETHOPRIM 100MG TABLET / ORAL AB RLD, RS 1982-07-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-486 TRIMETHOPRIM TABLET [MAYNE PHARMA] 5 Legacy NDC 20210219_8a0098dd-c316-4591-8e58-10531ff2048f.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51862-486-01 51862048601 100 TABLET in 1 BOTTLE (51862-486-01) 100 tablet 2016-07-18 0000-00-00 No No Current