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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62559-550-16ML - Milliliter62559-550836bbb6d-aebe-40c7-ba52-2156382c9c6112020-03-10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62559-550-1662559055016473 mL in 1 BOTTLE, PLASTIC (62559-550-16) 473 ml2020-02-110000-00-00NoNoCurrent