Home NDC 62559-550 Sulfamethoxazole and Trimethoprim
Product NDC 62559-550
11-digit product format 625590550
Labeler code 62559
Product ID 62559-550_c3c174a0-c992-4c5f-a8be-e113ffdeebcc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sulfamethoxazole and trimethoprim
Dosage form SUSPENSION
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application ANDA077612
Marketing category ANDA
Marketing start 2020-02-11
Marketing end 2023-12-31
Substance SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength 200 mg/5mL; mg/5mL
Pharmacologic classes Cytochrome P450 2C8 Inhibitors [MoA], Cytochrome P450 2C9 Inhibitors [MoA], Dihydrofolate Reductase Inhibitor Antibacterial [EPC], Dihydrofolate Reductase Inhibitors [MoA], Organic Cation Transporter 2 Inhibitors [MoA], Sulfonamide Antimicrobial [EPC], Sulfonamides [CS]
NDC exclude flag No
Listing certified through 0000-00-00
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 A077612-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM SULFAMETHOXAZOLE; TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL AB 2006-11-13
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A077612-001 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.
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 A077612-001 SULFAMETHOXAZOLE AND TRIMETHOPRIM 200MG/5ML;40MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** SUSPENSION / ORAL AB 2006-11-13 a50c72e98297…
Observed Orange Book normalized TE history# Captured, Edition, Application-product table Captured Edition Application-product TE code Order Source SHA-256 2026-08-01 22:54:32 2026-06 A077612-001 AB 1 a50c72e98297…
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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 62559-550-16 62559055016 473 mL in 1 BOTTLE, PLASTIC (62559-550-16) 473 ml 2020-02-11 0000-00-00 No No Current