SULINDAC
Sulindac Tablets USP, 150 mg and 200 mg Rx only
Approved
Approval ID
96c73bd2-4577-487d-a642-bd8f91e94c3a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Epic Pharma, LLC
DUNS: 827915443
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 Code42806-018
Application NumberANDA072710
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2023
Generic NameSULINDAC
INGREDIENTS (5)
POVIDONE K29/32Inactive
Code: 390RMW2PEQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SULINDACActive
Quantity: 150 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
SULINDAC
PRODUCT DETAILS
NDC Product Code42806-011
Application NumberANDA072711
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 20, 2023
Generic NameSULINDAC
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB