Misoprostol
Misoprostol Tablets GenBioPro, Inc.
Approved
Approval ID
4179736a-1cb2-4661-8c50-3d68ec7f4025
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 2, 2013
Manufacturers
FDA
GenBioPro Inc
DUNS: 078364058
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 Code43393-203
Application NumberANDA091667
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 2, 2013
FDA Product Classification
INGREDIENTS (4)
CROSPOVIDONEInactive
Code: 68401960MK
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT