Misoprostol
Misoprostol Tablets Novel Laboratories, Inc.
Approved
Approval ID
a46d05a2-5014-40ff-8f1b-9eca1b0aff3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2020
Manufacturers
FDA
Novel Laboratories, Inc.
DUNS: 793518643
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 Code40032-161
Application NumberANDA091667
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2020
FDA Product Classification
INGREDIENTS (4)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
Misoprostol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code40032-160
Application NumberANDA091667
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2020
FDA Product Classification
INGREDIENTS (4)
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
MISOPROSTOLActive
Quantity: 100 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT