PROPYLTHIOURACIL
Propylthiouracil Tablets, USP
Approved
Approval ID
ae65e8b0-91b2-4a3f-8e1a-279e47eee951
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
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 Code72162-2072
Application NumberANDA080154
Product Classification
M
Marketing Category
C73584
G
Generic Name
PROPYLTHIOURACIL
Product Specifications
Route of AdministrationORAL
Effective DateAugust 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
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT