SULINDAC
Sulindac Tablets USP, 150 mg and 200 mg Rx only
Approved
Approval ID
0feabf47-8d0d-48c0-b263-43db4969f39e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
PuraCap Laboratories LLC dba Blu Pharmaceuticals
DUNS: 080210964
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
SULINDAC
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code24658-771
Application NumberANDA072711
Product Classification
M
Marketing Category
C73584
G
Generic Name
SULINDAC
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 4, 2019
FDA Product Classification
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