SULINDAC
SULINDAC TABLETS USP
Approved
Approval ID
1fffe88d-50c8-45cf-ac7c-a62b665c89a8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 25, 2024
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
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 Code72789-374
Application NumberANDA072051
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 25, 2024
Generic Namesulindac
INGREDIENTS (4)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SULINDACActive
Quantity: 200 mg in 1 1
Code: 184SNS8VUH
Classification: ACTIB