Cytotec
Cytotec misoprostol tablets
Approved
Approval ID
4ab12da7-5731-4e06-bf1c-bc3f2e711f12
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 9, 2021
Manufacturers
FDA
Pfizer Laboratories Div Pfizer Inc
DUNS: 134489525
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 Code0025-1451
Application NumberNDA019268
Product Classification
M
Marketing Category
C73594
G
Generic Name
misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2021
FDA Product Classification
INGREDIENTS (4)
MISOPROSTOLActive
Quantity: 100 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
misoprostol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0025-1461
Application NumberNDA019268
Product Classification
M
Marketing Category
C73594
G
Generic Name
misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateJuly 9, 2021
FDA Product Classification
INGREDIENTS (4)
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT