Propylthiouracil
Propylthiouracil Tablets, USP Rx Only 8296421/0220F
Approved
Approval ID
d819e532-09ac-434a-84a6-636c4204c7aa
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 4, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Propylthiouracil
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68084-964
Application NumberNDA006188
Product Classification
M
Marketing Category
C73594
G
Generic Name
Propylthiouracil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 4, 2022
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLTHIOURACILActive
Quantity: 50 mg in 1 1
Code: 721M9407IY
Classification: ACTIB
SODIUM GLYCOLATEInactive
Code: B75E535IMI
Classification: IACT