Home NDC 12634-779 SULFAMETHOXAZOLE and TRIMETHOPRIM
Product NDC 12634-779
11-digit product format 126340779
Labeler code 12634
Product ID 12634-779_51ea5805-beef-4741-a63e-76bf0fe03153
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SULFAMETHOXAZOLE and TRIMETHOPRIM
Dosage form SUSPENSION
Route ORAL
Labeler Apotheca, Inc.
Application ANDA074650
Marketing category ANDA
Marketing start 2009-11-03
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 E
Listing certified through 2018-12-31
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 3 · 154 matching rows.
View current auxiliary records. · View the auxiliary file history.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29
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 · 43 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 2026-09-14 22:38:34 2026-08 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 84e616aacf4f…2026-08-18 06:07:40 2026-07 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL AB RS 1997-12-29 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 12634-779-02 SULFAMETHOXAZOLE and TRIMETHOPRIM 60 mL in 1 BOTTLE SUSPENSION 60 1 12634-779-04 SULFAMETHOXAZOLE and TRIMETHOPRIM 120 mL in 1 BOTTLE SUSPENSION 120 1 12634-779-06 SULFAMETHOXAZOLE and TRIMETHOPRIM 180 mL in 1 BOTTLE SUSPENSION 180 1 12634-779-08 SULFAMETHOXAZOLE and TRIMETHOPRIM 240 mL in 1 BOTTLE SUSPENSION 240 1 12634-779-11 SULFAMETHOXAZOLE and TRIMETHOPRIM 100 mL in 1 BOTTLE SUSPENSION 100 1 12634-779-19 SULFAMETHOXAZOLE and TRIMETHOPRIM 200 mL in 1 BOTTLE SUSPENSION 200 1
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SULFAMETHOXAZOLE ACTIVE INGREDIENT JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 TRIMETHOPRIM ACTIVE INGREDIENT AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 SULFAMETHOXAZOLE ACTIVE MOIETY JE42381TNV SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 TRIMETHOPRIM ACTIVE MOIETY AN164J8Y0X SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 ALCOHOL INACTIVE INGREDIENT 3K9958V90M SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 ANHYDROUS CITRIC ACID INACTIVE INGREDIENT XF417D3PSL SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 CARBOXYMETHYLCELLULOSE SODIUM INACTIVE INGREDIENT K679OBS311 SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 CHERRY INACTIVE INGREDIENT BUC5I9595W SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 FD&C RED NO. 40 INACTIVE INGREDIENT WZB9127XOA SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 FD&C YELLOW NO. 6 INACTIVE INGREDIENT H77VEI93A8 SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 SACCHARIN SODIUM INACTIVE INGREDIENT SB8ZUX40TY SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 SODIUM BENZOATE INACTIVE INGREDIENT OJ245FE5EU SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 SORBITOL INACTIVE INGREDIENT 506T60A25R SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 12634-779 SULFAMETHOXAZOLE AND TRIMETHOPRIM SUSPENSION [APOTHECA, INC.] 1 Legacy NDC, 6 package rows 20100428_fea44910-400c-4688-bedc-bbb1615cd8f5.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 12634-779-02 12634077902 60 mL in 1 BOTTLE 60 ml Historical 12634-779-04 12634077904 120 mL in 1 BOTTLE 120 ml Historical 12634-779-06 12634077906 180 mL in 1 BOTTLE 180 ml Historical 12634-779-08 12634077908 240 mL in 1 BOTTLE 240 ml Historical 12634-779-11 12634077911 100 mL in 1 BOTTLE 100 ml Historical 12634-779-19 12634077919 200 mL in 1 BOTTLE 200 ml Historical