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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

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SULINDAC - FDA Drug Approval Details