Premier Value Arthritis 8 Hour

Product NDC
68016-336
11-digit product format
680160336
Labeler code
68016
Product ID
68016-336_d7965bc5-9443-4041-9279-ae703dc067d7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Premier Value
Application
ANDA076200
Marketing category
ANDA
Marketing start
2002-04-30
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-336-01EA - Each68016-336390beab4-3923-44e3-8d77-66c22f9fbdb612014-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48PREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30PREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPPREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-336PREMIER VALUE ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [PREMIER VALUE]4Legacy NDC20241228_64fa67b4-b143-4789-a472-af047647a75e.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68016-336-0168016033601100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68016-336-01) 2002-04-300000-00-00NoNoCurrent
68016-336-506801603365050 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (68016-336-50) 2002-04-300000-00-00NoNoCurrent