FDA.reportPublic FDA data

Premier Value Arthritis Pain Reliever

Product NDC
68016-340
11-digit product format
680160340
Labeler code
68016
Product ID
68016-340_f7294172-76af-4571-a424-ebf27a43f67c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
Chain Drug Consortium, LLC
Application
ANDA078569
Marketing category
ANDA
Marketing start
2012-12-21
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
68016-340-082020-01-31C16284748780-19d75b9d0-4e7c-f424-e053-dadaa90a57ceDrug Facts
68016-340-402020-01-31C16284748780-19d75b9d0-4e7c-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-340-08Premier Value Arthritis Pain Reliever80 in 1 BOTTLETABLET, EXTENDED RELEASE802
68016-340-40Premier Value Arthritis Pain Reliever40 in 1 BOTTLETABLET, EXTENDED RELEASE402

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-340-08EA - Each68016-340ba65574e-3731-4d4e-bf8d-4d1ee7f0477612014-07-02
68016-340-40EA - Each68016-3404e968dbd-0441-4995-b092-22f73a9df50712014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
GELATININACTIVE INGREDIENT2G86QN327LPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1APREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-340PREMIER VALUE ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, EXTENDED RELEASE [CHAIN DRUG CONSORTIUM, LLC]2Legacy NDC, 2 package rows20151014_e12098ad-8af1-45f3-817a-62dda19a9449.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNe12098ad-8af1-45f3-817a-62dda19a94492
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDe12098ad-8af1-45f3-817a-62dda19a94492
11483998 HR APAP 650 MG Extended Release Oral TabletSYe12098ad-8af1-45f3-817a-62dda19a94492
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYe12098ad-8af1-45f3-817a-62dda19a94492

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68016-340-086801603400880 in 1 BOTTLEHistorical
68016-340-406801603404040 in 1 BOTTLEHistorical