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Salsalate

Salsalate Tablets, USP500 mg and 750 mgRx Only

Approved
Approval ID

b721701c-3cdb-44f6-b88a-c712cb17175e

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 23, 2023

Manufacturers
FDA

Bryant Ranch Prepack

DUNS: 171714327

Products 1

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 Code63629-9247
Product Classification
G
Generic Name
Salsalate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 10, 2020
FDA Product Classification

INGREDIENTS (9)

SALSALATEActive
Quantity: 500 mg in 1 1
Code: V9MO595C9I
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE AInactive
Code: H8AV0SQX4D
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TRIACETINInactive
Code: XHX3C3X673
Classification: IACT

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Salsalate - FDA Drug Approval Details