SULINDAC
SULINDAC TABLETS USP
Approved
Approval ID
6db52fd3-172f-47ab-8aa6-4f3d031c6b25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2021
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
sulindac
PRODUCT DETAILS
NDC Product Code71335-0413
Application NumberANDA072051
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 27, 2022
Generic Namesulindac
INGREDIENTS (4)
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT