Acetaminophen-APAP 8 Hour

Product NDC
41520-336
11-digit product format
415200336
Labeler code
41520
Product ID
41520-336_a833a491-7e96-4c0e-b534-38f757335f9e
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
41520-336-232020-01-31C16284748780-19d75b9d1-174f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41520-336-23Acetaminophen-APAP 8 Hour24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE241

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41520-336ACETAMINOPHEN-APAP 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN SALES COMPANY]1Legacy NDC, 1 package rows20130211_d8259f15-ef0f-41bf-a038-0be4eacb2d79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNd8259f15-ef0f-41bf-a038-0be4eacb2d791
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDd8259f15-ef0f-41bf-a038-0be4eacb2d791
11483998 HR APAP 650 MG Extended Release Oral TabletSYd8259f15-ef0f-41bf-a038-0be4eacb2d791
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYd8259f15-ef0f-41bf-a038-0be4eacb2d791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
41520-336-234152003362324 in 1 BOTTLEHistorical