Misoprostol
Misoprostol Tablets GenBioPro, Inc.
Approved
Approval ID
99ce26c1-4e24-4b26-b76d-0b25c8d71313
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
NDC Product Code43393-022
Application NumberANDA091667
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 9, 2024
Generic NameMisoprostol
INGREDIENTS (4)
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONE, UNSPECIFIEDInactive
Code: 2S7830E561
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB