Home NDC 50090-5786-0 Sulfamethoxazole and Trimethoprim
Product NDC 50090-5786
Requested package NDC 50090-5786-0
11-digit product format 500905786
Labeler code 50090
Product ID 50090-5786_6bc0877b-0399-4abd-bfc1-c9c502ec7617
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form SUSPENSION
Route ORAL
Labeler A-S Medication Solutions
Application ANDA077785
Marketing category ANDA
Marketing start 2007-01-24
Marketing end 0000-00-00
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength 200 mg/5mL; mg/5mL
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 2022-12-31
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 50090-5786 50090-5786-0 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 50090-5786 50090-5786-0 D Discontinued by firm excluded / ndc_excluded.zip f5e01cc5f278…a2eaf40c39c3…
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 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077785-001 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 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A077785-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB 2007-01-24 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-5786 SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [A-S MEDICATION SOLUTIONS] 3 Legacy NDC 20230208_4eb92391-3964-4213-9099-4404e0c65c49.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 50090-5786-0 50090578600 473 mL in 1 BOTTLE (50090-5786-0) 473 ml 2021-10-08 0000-00-00 No No Current