Home NDC 68788-9086 Sulfamethoxazole and Trimethoprim
Product NDC 68788-9086
11-digit product format 687889086
Labeler code 68788
Product ID 68788-9086_dfb4ac13-2bbc-4bcb-8914-e12bb2b79850
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form TABLET
Route ORAL
Labeler Preferred Pharmaceuticals, Inc
Application ANDA078060
Marketing category ANDA
Marketing start 2007-01-25
Marketing end 0000-00-00
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength 800 mg/1; mg/1
Pharmacologic classes Sulfonamide Antimicrobial [EPC],Sulfonamides [CS],Cytochrome P450 2C9 Inhibitors [MoA],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 2 · 84 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 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 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078060-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 2007-01-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A078060-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 2007-01-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFAMETHOXAZOLE ACTIVE INGREDIENT JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 TRIMETHOPRIM ACTIVE INGREDIENT AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 SULFAMETHOXAZOLE ACTIVE MOIETY JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 TRIMETHOPRIM ACTIVE MOIETY AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 DOCUSATE SODIUM INACTIVE INGREDIENT F05Q2T2JA0 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 POVIDONES INACTIVE INGREDIENT FZ989GH94E SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ SULFAMETHOXAZOLE AND TRIMETHOPRIM TABLET [PREFERRED PHARMACEUTICALS, INC] 3
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.