SULINDAC
Sulindac Tablets USP, 200 mg Rx only
Approved
Approval ID
d94e8865-d151-4fb1-bacd-f4e43819e3c2
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 1, 2022
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
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 Code71205-648
Application NumberANDA072711
Product Classification
M
Marketing Category
C73584
G
Generic Name
SULINDAC
Product Specifications
Route of AdministrationORAL
Effective DateMarch 1, 2022
FDA Product Classification
INGREDIENTS (5)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
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