Propylthiouracil
Propylthiouracil Tablets, USP
Approved
Approval ID
a57c49ae-d659-49fa-84e3-cf6d1f9e6f97
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2021
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
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 Code0228-2348
Application NumberANDA080172
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propylthiouracil
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2021
FDA Product Classification
INGREDIENTS (6)
PROPYLTHIOURACILActive
Quantity: 50 mg in 1 1
Code: 721M9407IY
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT