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
NDC Product Code0591-5660
Application NumberANDA071795
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 22, 2023
Generic NameSulindac
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
NDC Product Code0591-5661
Application NumberANDA071891
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 22, 2023
Generic NameSulindac
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