Salsalate
Salsalate Tablets, USP500 mg and 750 mgRx Only
Approved
Approval ID
213f0930-4a4a-4894-90b9-70c12daaa093
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 20, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Salsalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-513
Product Classification
G
Generic Name
Salsalate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (10)
SALSALATEActive
Quantity: 750 mg in 1 1
Code: V9MO595C9I
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
Salsalate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-512
Product Classification
G
Generic Name
Salsalate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 20, 2023
FDA Product Classification
INGREDIENTS (10)
SALSALATEActive
Quantity: 500 mg in 1 1
Code: V9MO595C9I
Classification: ACTIB
CARNAUBA WAXInactive
Code: R12CBM0EIZ
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT