Acetaminophen - APAP 8 Hour

Product NDC
63941-336
11-digit product format
639410336
Labeler code
63941
Product ID
63941-336_69d1cc24-301c-41dc-8e64-b00468c01942
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Valu Merchandisers Company
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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63941-336ACETAMINOPHEN - APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [VALU MERCHANDISERS COMPANY]3Legacy NDC20241228_b5ddc01d-40dc-400a-8a58-1e3a97d15142.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63941-336-506394103365050 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (63941-336-50) 2002-04-300000-00-00NoNoCurrent