FDA.reportPublic FDA data

Salsalate

Product NDC
65162-513
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SALSALATE750 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiV9MO595C9I
Rxcui312899, 583170

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65162-513-102020-07-20C16284748780-19d75b9d0-332b-f424-e053-dadaa90a57ceSalsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-112020-07-20C16284748780-19d75b9d0-332b-f424-e053-dadaa90a57ceSalsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-502020-07-20C16284748780-19d75b9d0-332b-f424-e053-dadaa90a57ceSalsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-102020-01-31C16284748780-19d75b9d0-332b-f424-e053-dadaa90a57ceSalsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-112020-01-31C16284748780-19d75b9d0-332b-f424-e053-dadaa90a57ceSalsalate Tablets, USP 500 mg and 750 mg Rx Only
65162-513-502020-01-31C16284748780-19d75b9d0-332b-f424-e053-dadaa90a57ceSalsalate Tablets, USP 500 mg and 750 mg Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65162-513-10Salsalate100 in 1 BOTTLETABLET10014
65162-513-11Salsalate1000 in 1 BOTTLETABLET100014
65162-513-50Salsalate500 in 1 BOTTLETABLET50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-513-10EA - Each65162-513adc30e56-22d3-4ad7-9278-489ff119740f12012-07-24
65162-513-11EA - Each65162-5131e0e50af-f056-4ef7-864e-3bfd638f47c712012-07-24
65162-513-50EA - Each65162-5138a027b39-5ba7-4d76-97cf-cef7de39146012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SALSALATEACTIVE INGREDIENTV9MO595C9ISALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
SALSALATEACTIVE MOIETYV9MO595C9ISALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ASALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSALSALATE TABLET [AMNEAL PHARMACEUTICALS]3
SALSALATEACTIVE INGREDIENTV9MO595C9ISALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
SALSALATEACTIVE MOIETYV9MO595C9ISALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GSALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4SALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSALSALATE TABLET [CARILION MATERIALS MANAGEMENT]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-513SALSALATE TABLET [AMNEAL PHARMACEUTICALS LLC]14Current NDC, Legacy NDC, 3 package rows20241031_213f0930-4a4a-4894-90b9-70c12daaa093.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312899salsalate 500 MG Oral TabletPSN213f0930-4a4a-4894-90b9-70c12daaa09314
583170salsalate 750 MG Oral TabletPSN213f0930-4a4a-4894-90b9-70c12daaa09314
312899salsalate 500 MG Oral TabletSCD213f0930-4a4a-4894-90b9-70c12daaa09314
583170salsalate 750 MG Oral TabletSCD213f0930-4a4a-4894-90b9-70c12daaa09314
583170salsalate 750 MG Oral TabletPSN17d708f2-e078-44bf-ace1-a8f47b3aa1632
583170salsalate 750 MG Oral TabletSCD17d708f2-e078-44bf-ace1-a8f47b3aa1632

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-513-1065162051310100 TABLET in 1 BOTTLE (65162-513-10) 100 tablet2010-09-240000-00-00NoNoCurrent
65162-513-11651620513111000 TABLET in 1 BOTTLE (65162-513-11) 1000 tablet2010-09-240000-00-00NoNoCurrent
65162-513-5065162051350500 TABLET in 1 BOTTLE (65162-513-50) 500 tablet2010-09-240000-00-00NoNoCurrent