Acetaminophen

Product NDC
41520-333
11-digit product format
415200333
Labeler code
41520
Product ID
41520-333_220a48c3-2d87-4b82-8c41-caec5c77bc81
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Sales 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
2019-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41520-333-012020-01-31C16284748780-19d75b9cf-e3cf-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-333-01Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-333ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]1Legacy NDC, 1 package rows20130211_bfaa0ee9-37be-431f-a19d-2a4f3f7b3108.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNbfaa0ee9-37be-431f-a19d-2a4f3f7b31081
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDbfaa0ee9-37be-431f-a19d-2a4f3f7b31081
11483998 HR APAP 650 MG Extended Release Oral TabletSYbfaa0ee9-37be-431f-a19d-2a4f3f7b31081
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYbfaa0ee9-37be-431f-a19d-2a4f3f7b31081

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
41520-333-0141520033301100 in 1 BOTTLEHistorical