Home NDC 43386-330 Trimethoprim
Product NDC 43386-330
11-digit product format 433860330
Labeler code 43386
Product ID 43386-330_6a57562b-424f-40ef-9b86-fa0e66c1c344
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Lupin Pharmaceuticals,Inc.
Application ANDA091437
Marketing category ANDA
Marketing start 2011-06-24
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 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.
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 43386-330-01 Trimethoprim 100 in 1 BOTTLE TABLET 100 6
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 INGREDIENT AN164J8Y0X TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 TRIMETHOPRIM ACTIVE MOIETY AN164J8Y0X TRIMETHOPRIM TABLET [AVKARE, INC.] 1 TRIMETHOPRIM ACTIVE MOIETY AN164J8Y0X TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U TRIMETHOPRIM TABLET [AVKARE, INC.] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X TRIMETHOPRIM TABLET [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 TRIMETHOPRIM TABLET [AVKARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIMETHOPRIM TABLET [AVKARE, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRIMETHOPRIM TABLET [AVKARE, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ TRIMETHOPRIM TABLET [AVKARE, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRIMETHOPRIM TABLET [GAVIS PHARMACEUTICALS, LLC] 1 WATER INACTIVE INGREDIENT 059QF0KO0R TRIMETHOPRIM TABLET [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43386-330 TRIMETHOPRIM TABLET [LUPIN PHARMACEUTICALS,INC.] 6 Current NDC, Legacy NDC, 1 package rows 20241204_249e938d-f181-47c4-a082-372d65462f33.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 43386-330-01 43386033001 100 TABLET in 1 BOTTLE (43386-330-01) 100 tablet 2011-06-24 0000-00-00 No No Current