Sulfamethoxazole and Trimethoprim

Product NDC
42292-028
11-digit product format
422920028
Labeler code
42292
Product ID
42292-028_96c85fda-bf8a-222b-e053-2995a90a5a34
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sulfamethoxazole and Trimethoprim
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA090624
Marketing category
ANDA
Marketing start
2016-08-24
Marketing end
2021-04-30
Substance
SULFAMETHOXAZOLE; TRIMETHOPRIM
Active strength
800 mg/1; mg/1
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
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
42292-028-01EA - Each42292-02882d7d58a-f7df-454e-8242-7401b034520012016-12-07
42292-028-08EA - Each42292-02882c38478-2a7a-47f8-9fc7-c8b627d74c2212016-12-07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42292-028-084229200280880 BLISTER PACK in 1 BOX, UNIT-DOSE (42292-028-08) > 1 TABLET in 1 BLISTER PACK (42292-028-01) 80 blister pack2016-08-242021-04-30NoNoCurrent