Home NDC 68788-9102 Sulfamethoxazole and Trimethoprim
Product NDC 68788-9102
11-digit product format 687889102
Labeler code 68788
Product ID 68788-9102_dbd7c8c8-2a47-491c-8218-1fcc3d3a1acf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sulfamethoxazole and Trimethoprim
Dosage form SUSPENSION
Route ORAL
Labeler Preferred Pharmaceuticals
Application ANDA074650
Marketing category ANDA
Marketing start 2004-08-06
Marketing end 0000-00-00
Substance SULFAMETHOXAZOL
Active strength 200 mg/5mL; mg/5mL
Pharmacologic classes Sulfonamide Ant
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…