Propylthiouracil
PROPYLTHIOURACIL TABLETS, USP
Approved
Approval ID
53c5f586-3e72-479d-89ba-379683c8f6ba
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 26, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-606
Application NumberANDA080016
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propylthiouracil
Product Specifications
Route of AdministrationORAL
Effective DateDecember 26, 2023
FDA Product Classification
INGREDIENTS (4)
PROPYLTHIOURACILActive
Quantity: 50 mg in 1 1
Code: 721M9407IY
Classification: ACTIB
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT