Propylthiouracil
PROPYLTHIOURACIL TABLETS, USP
Approved
Approval ID
ff603c99-6620-4945-acdc-c9150b6f77d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 18, 2011
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
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 Code42254-010
Application NumberANDA080154
Product Classification
M
Marketing Category
C73584
G
Generic Name
Propylthiouracil
Product Specifications
Route of AdministrationORAL
Effective DateAugust 25, 2011
FDA Product Classification
INGREDIENTS (6)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLTHIOURACILActive
Quantity: 50 mg in 1 1
Code: 721M9407IY
Classification: ACTIB
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT