misoprostol
Misoprostol Tablets
Approved
Approval ID
c5d0b74b-e5bc-4e81-91e8-4bfc587bf54c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
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 Code43393-020
Application NumberNDA019268
Product Classification
M
Marketing Category
C73605
G
Generic Name
MISOPROSTOL
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (4)
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB