Acetaminophen 8 Hour

Product NDC
59779-336
11-digit product format
597790336
Labeler code
59779
Product ID
59779-336_59d0f3f6-06f2-43f1-b220-4eedeb32e663
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
CVS Pharmacy
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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59779-336-012020-01-31C16284748780-19d75b9cf-d841-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59779-336-01Acetaminophen 8 Hour100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59779-336ACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [CVS PHARMACY]1Legacy NDC, 1 package rows20130307_90461bb3-a28e-4d34-b013-6a7981b338c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN90461bb3-a28e-4d34-b013-6a7981b338c71
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD90461bb3-a28e-4d34-b013-6a7981b338c71
11483998 HR APAP 650 MG Extended Release Oral TabletSY90461bb3-a28e-4d34-b013-6a7981b338c71
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY90461bb3-a28e-4d34-b013-6a7981b338c71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
59779-336-0159779033601100 in 1 BOTTLEHistorical