Trimethoprim
TRIMETHOPRIM TABLETS, USP Rx only
Approved
Approval ID
95a1572c-6109-4d1f-bf92-262015a7654e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 2, 2022
Manufacturers
FDA
Novitium Pharma LLC
DUNS: 080301870
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Trimethoprim
PRODUCT DETAILS
NDC Product Code70954-541
Application NumberANDA216393
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 3, 2022
Generic NameTrimethoprim
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIMETHOPRIMActive
Quantity: 100 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT