Salsalate

Product NDC: 65162-513
Requested package NDC: 65162-513-11
11-digit product format: 651620513
Labeler code: 65162
Product ID: 65162-513_6b990a95-3932-4771-adb1-84bfe4c456de
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Salsalate
Dosage form: TABLET
Route: ORAL
Labeler: Amneal Pharmaceuticals LLC
Marketing category: UNAPPROVED DRUG OTHER
Marketing start: 2010-09-24
Substance: SALSALATE
Active strength: 750 mg/1
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65162-513	65162-513-11	I	Inactivated by FDA		excluded / ndc_excluded.zip	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65162-513	65162-513-11	E	Excluded after deficient or non-compliant submission was not corrected		excluded / ndc_excluded.zip	`110d247fa046…`	`a55b01930146…`

Additional Listing Data#

Finished product: Yes
Brand name base: Salsalate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SALSALATE	750 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V9MO595C9I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
312899	Internal RxNorm lookup
583170	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213f0930-4a4a-4894-90b9-70c12daaa093	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
65162-513-10	2020-07-20	Salsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-11	2020-07-20	Salsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-50	2020-07-20	Salsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-10	2020-01-31	Salsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-11	2020-01-31	Salsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-50	2020-01-31	Salsalate Tablets, USP 500 mg and 750 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65162-513-10	Salsalate	100 in 1 BOTTLE	TABLET	100	14
65162-513-11	Salsalate	1000 in 1 BOTTLE	TABLET	1000	14
65162-513-50	Salsalate	500 in 1 BOTTLE	TABLET	500	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65162-513-10	EA - Each	65162-513	adc30e56-22d3-4ad7-9278-489ff119740f	1	2012-07-24
65162-513-11	EA - Each	65162-513	1e0e50af-f056-4ef7-864e-3bfd638f47c7	1	2012-07-24
65162-513-50	EA - Each	65162-513	8a027b39-5ba7-4d76-97cf-cef7de391460	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SALSALATE	ACTIVE INGREDIENT	V9MO595C9I	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
SALSALATE	ACTIVE MOIETY	V9MO595C9I	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
POLYETHYLENE GLYCOL	INACTIVE INGREDIENT	3WJQ0SDW1A	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SALSALATE TABLET [AMNEAL PHARMACEUTICALS]	3
SALSALATE	ACTIVE INGREDIENT	V9MO595C9I	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
SALSALATE	ACTIVE MOIETY	V9MO595C9I	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
CROSCARMELLOSE SODIUM	INACTIVE INGREDIENT	M28OL1HH48	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65162-513	SALSALATE TABLET [AMNEAL PHARMACEUTICALS LLC]	14	Current NDC, Legacy NDC, 3 package rows	20241031_213f0930-4a4a-4894-90b9-70c12daaa093.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Salsalate	SALSALATE	Amneal Pharmaceuticals LLC	213f0930-4a4a-4894-90b9-70c12daaa093	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier ndc (package): 65162-513-11 ndc (product): 65162-513 ndc11 (package): 65162051311

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V9MO595C9I	SALSALATE	552-94-3	SALSALATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
312899	salsalate 500 MG Oral Tablet	PSN	213f0930-4a4a-4894-90b9-70c12daaa093	14
583170	salsalate 750 MG Oral Tablet	PSN	213f0930-4a4a-4894-90b9-70c12daaa093	14
312899	salsalate 500 MG Oral Tablet	SCD	213f0930-4a4a-4894-90b9-70c12daaa093	14
583170	salsalate 750 MG Oral Tablet	SCD	213f0930-4a4a-4894-90b9-70c12daaa093	14
583170	salsalate 750 MG Oral Tablet	PSN	17d708f2-e078-44bf-ace1-a8f47b3aa163	2
583170	salsalate 750 MG Oral Tablet	SCD	17d708f2-e078-44bf-ace1-a8f47b3aa163	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65162-513-11	65162051311	1000 TABLET in 1 BOTTLE (65162-513-11)	1000 tablet	2010-09-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Salsalate Tablets, USP 500 mg and 750 mg Rx Only	Amneal Pharmaceuticals LLC \| Amneal Pharmaceuticals of New York, LLC	2024-10-30	HUMAN PRESCRIPTION DRUG LABEL	14
Salsalate Tablets, USP	Carilion Materials Management	2011-07-07	HUMAN PRESCRIPTION DRUG LABEL	2