Sulfamethoxazole and Trimethoprim

Product NDC
63629-1969
11-digit product format
636291969
Labeler code
63629
Product ID
63629-1969_159e876c-e550-400e-b14d-1e0231e018b0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sulfamethoxazole and trimethoprim
Dosage form
SUSPENSION
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077612
Marketing category
ANDA
Marketing start
2020-02-11
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1969-1ML - Milliliter63629-1969a5ccfe83-20e9-4572-88c6-7494b783bb8512021-03-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1969-163629196901473 mL in 1 BOTTLE (63629-1969-1) 473 ml2021-12-210000-00-00NoNoCurrent