Trimethoprim
TRIMETHOPRIM TABLETS, USP Rx only
Approved
Approval ID
8a0098dd-c316-4591-8e58-10531ff2048f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2021
Manufacturers
FDA
Mayne Pharma
DUNS: 867220261
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 Code51862-486
Application NumberNDA018679
Product Classification
M
Marketing Category
C73594
G
Generic Name
Trimethoprim
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 16, 2021
FDA Product Classification
INGREDIENTS (7)
TRIMETHOPRIMActive
Quantity: 100 mg in 1 1
Code: AN164J8Y0X
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEInactive
Code: O7TSZ97GEP
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT