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 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 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.
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 2026-08-01 22:54:32 2026-06 A074650-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML SUSPENSION / ORAL 1997-12-29 a50c72e98297…
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