FDA.reportPublic FDA data

ARTHRITIS PAIN RELIEF

Product NDC
59779-340
11-digit product format
597790340
Labeler code
59779
Product ID
59779-340_6d59e492-cf61-43aa-af10-4e0bfc2e38b4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
CVS PHARMACY
Application
ANDA078569
Marketing category
ANDA
Marketing start
2014-02-14
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-340-082020-01-31C16284748780-19d75b9d0-faab-f424-e053-dadaa90a57ceDrug Facts
59779-340-202020-01-31C16284748780-19d75b9d0-faab-f424-e053-dadaa90a57ceDrug Facts
59779-340-822020-01-31C16284748780-19d75b9d1-18ab-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-340-82ARTHRITIS PAIN RELIEF80 in 1 BOTTLETABLET, EXTENDED RELEASE802
59779-340-08ARTHRITIS PAIN RELIEF1 in 1 CARTONTABLET, EXTENDED RELEASE11
59779-340-08ARTHRITIS PAIN RELIEF80 in 1 BOTTLETABLET, EXTENDED RELEASE801
59779-340-20ARTHRITIS PAIN RELIEF20 in 1 BOTTLETABLET, EXTENDED RELEASE201
59779-340-20ARTHRITIS PAIN RELIEF1 in 1 CARTONTABLET, EXTENDED RELEASE11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
GELATININACTIVE INGREDIENT2G86QN327LARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-340ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]2Legacy NDC, 1 package rows20180115_b57e5a38-ff6a-4e72-b5e3-3952d785f825.zip
59779-340ARTHRITIS PAIN RELIEF (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CVS PHARMACY]1Legacy NDC, 4 package rows20140311_e0aa4c5d-88c0-4484-9185-f33888421dd3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNb57e5a38-ff6a-4e72-b5e3-3952d785f8252
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDb57e5a38-ff6a-4e72-b5e3-3952d785f8252
11483998 HR APAP 650 MG Extended Release Oral TabletSYb57e5a38-ff6a-4e72-b5e3-3952d785f8252
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYb57e5a38-ff6a-4e72-b5e3-3952d785f8252
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNe0aa4c5d-88c0-4484-9185-f33888421dd31
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDe0aa4c5d-88c0-4484-9185-f33888421dd31
11483998 HR APAP 650 MG Extended Release Oral TabletSYe0aa4c5d-88c0-4484-9185-f33888421dd31
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYe0aa4c5d-88c0-4484-9185-f33888421dd31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-340-08597790340081 in 1 CARTONHistorical
59779-340-205977903402020 in 1 BOTTLEHistorical
59779-340-825977903408280 in 1 BOTTLEHistorical