Misoprostol
Misoprostol Tablets Lupin Pharmaceuticals, Inc
Approved
Approval ID
8642b8e4-d1bb-f12a-e053-2a91aa0a14bf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 17, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
Products 1
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 Code68071-4843
Application NumberANDA091667
Product Classification
M
Marketing Category
C73584
G
Generic Name
Misoprostol
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 17, 2021
FDA Product Classification
INGREDIENTS (4)
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CROSPOVIDONEInactive
Code: 2S7830E561
Classification: IACT
MISOPROSTOLActive
Quantity: 200 ug in 1 1
Code: 0E43V0BB57
Classification: ACTIB