Sulindac
Sulindac Tablets, USPRx only
Approved
Approval ID
d8b9d517-5dd4-4c6b-8aa0-736bce87e7b4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 22, 2023
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Sulindac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-5660
Application NumberANDA071795
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulindac
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (5)
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Sulindac
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-5661
Application NumberANDA071891
Product Classification
M
Marketing Category
C73584
G
Generic Name
Sulindac
Product Specifications
Route of AdministrationORAL
Effective DateMay 22, 2023
FDA Product Classification
INGREDIENTS (5)
SULINDACActive
Quantity: 150 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT