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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42571-253
Application NumberANDA216872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2022
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42571-254
Application NumberANDA216872
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateNovember 7, 2022
FDA Product Classification
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