PROPYLTHIOURACIL
Propylthiouracil Tablets, USP
Approved
Approval ID
84eae11a-b572-4570-b288-ac2cdd374186
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 15, 2023
Manufacturers
FDA
QUAGEN PHARMACEUTICALS LLC
DUNS: 073645339
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 Code70752-171
Application NumberANDA080154
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPYLTHIOURACIL
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 15, 2023
FDA Product Classification
INGREDIENTS (6)
PROPYLTHIOURACILActive
Quantity: 50 mg in 1 1
Code: 721M9407IY
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT