Manufacturing Establishments1
FDA-registered manufacturing facilities and establishments involved in the production, packaging, or distribution of this drug product.
Blenheim Pharmacal Inc.
GenBioPro Inc
171434587
Products1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Misoprostol
Product Details
NDC Product Code
43393-203Application Number
ANDA091667Marketing Category
ANDA (C73584)Route of Administration
ORALEffective Date
January 2, 2013CROSPOVIDONEInactive
Code: 68401960MKClass: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61UClass: IACT
MisoprostolActive
Code: 0E43V0BB57Class: ACTIBQuantity: 200 ug in 1 1
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEYClass: IACT