MISOPROSTOL
Misoprostol Tablets
Approved
Approval ID
54d26ca3-d309-4048-8699-a04b3854ef9c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2022
Manufacturers
FDA
Micro Labs Limited
DUNS: 862174955
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Misoprostol
PRODUCT DETAILS
NDC Product Code42571-253
Application NumberANDA216872
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2022
Generic NameMisoprostol
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MISOPROSTOLActive
Quantity: 100 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
Misoprostol
PRODUCT DETAILS
NDC Product Code42571-254
Application NumberANDA216872
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateNovember 7, 2022
Generic NameMisoprostol
INGREDIENTS (6)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB