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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70954-541
Application NumberANDA216393
Product Classification
M
Marketing Category
C73584
G
Generic Name
Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateNovember 3, 2022
FDA Product Classification
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