Propylthiouracil
Propylthiouracil Tablets, USP
Approved
Approval ID
a251e4cb-01f1-4fd8-bd30-362126b85073
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 17, 2023
Manufacturers
FDA
Macleods Pharmaceuticals Limited
DUNS: 862128535
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 Code33342-314
Application NumberANDA208867
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propylthiouracil
Product Specifications
Route of AdministrationORAL
Effective DateMay 18, 2023
FDA Product Classification
INGREDIENTS (5)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLTHIOURACILActive
Quantity: 50 mg in 1 1
Code: 721M9407IY
Classification: ACTIB
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT