Home NDC 50090-1541-3 Sulfamethoxazole and Trimethoprim
Product NDC 50090-1541
Requested package NDC 50090-1541-3
11-digit product format 500901541
Labeler code 50090
Product ID 50090-1541_4a6490d5-753f-4ddd-bf6b-0ca2a6c278f5
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form TABLET
Route ORAL
Labeler A-S Medication Solutions
Application ANDA071017
Marketing category ANDA
Marketing start 1986-08-25
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 2021-12-31
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25
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 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A071017-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 800MG;160MG TABLET / ORAL AB 1986-08-25 782e0a99824c…2021-12-28 21:50 UTC 2021-12 A071017-002 SULFAMETHOXAZOLE AND TRIMETHOPRIM 400MG;80MG TABLET / ORAL AB 1986-08-25 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
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 50090-1541-3 50090154103 28 TABLET in 1 BOTTLE (50090-1541-3) 28 tablet 2014-12-17 0000-00-00 No No Current