Home NDC 42291-845 Trimethoprim
Product NDC 42291-845
11-digit product format 422910845
Labeler code 42291
Product ID 42291-845_641a1680-b694-73fb-e053-2a91aa0a208f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name trimethoprim
Dosage form TABLET
Route ORAL
Labeler AvKARE, Inc.
Application ANDA091437
Marketing category ANDA
Marketing start 2013-05-06
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 2020-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 42291-845-90 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 42291-845-90 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 42291-845-90 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 42291-845-90 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 42291-845-90 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 42291-845-90 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 42291-845-90 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 42291-845-90 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 42291-845-90 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 42291-845-90 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 42291-845-90 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 42291-845-90 557ba5c1ecfa…9c80585c8c6e…
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 A091437-001 TRIMETHOPRIM TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091437-001 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 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091437-001 TRIMETHOPRIM 100MG TABLET / ORAL AB 2011-06-15 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TRIMETHOPRIM ACTIVE INGREDIENT AN164J8Y0X TRIMETHOPRIM TABLET [AVKARE, INC.] 1 TRIMETHOPRIM ACTIVE MOIETY AN164J8Y0X TRIMETHOPRIM TABLET [AVKARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIMETHOPRIM TABLET [AVKARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRIMETHOPRIM TABLET [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIMETHOPRIM TABLET [AVKARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIMETHOPRIM TABLET [AVKARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRIMETHOPRIM TABLET [AVKARE, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIMETHOPRIM TABLET [AVKARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRIMETHOPRIM TABLET [AVKARE, INC.] 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 · 2 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 42291-845-90 42291084590 90 TABLET in 1 BOTTLE (42291-845-90) 90 tablet 2013-05-06 0000-00-00 No No Current