misoprostol
Misoprostol Tablets
Approved
Approval ID
a5e5413d-bc22-4ae1-959b-0eb0430dbd38
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 19, 2012
Manufacturers
FDA
H.J. Harkins Company, Inc.
DUNS: 147681894
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
misoprostol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code52959-692
Application NumberNDA019268
Product Classification
M
Marketing Category
C73594
G
Generic Name
misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 19, 2012
FDA Product Classification
INGREDIENTS (4)
hypromellosesInactive
Code: 3NXW29V3WO
Classification: IACT
misoprostolActive
Quantity: 100 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
hydrogenated castor oilInactive
Code: ZF94AP8MEY
Classification: IACT
cellulose, microcrystallineInactive
Code: OP1R32D61U
Classification: IACT