Acetaminophen 8 Hour

Product NDC
41163-336
11-digit product format
411630336
Labeler code
41163
Product ID
41163-336_858cc5c1-fa49-4d6b-98b4-608d507d03a2
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Supervalu Inc.
Application
ANDA076200
Marketing category
ANDA
Marketing start
2013-08-13
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
41163-336-012020-01-31C16284748780-19d75b9d0-846a-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-336-01Acetaminophen 8 Hour1 in 1 CARTONTABLET, FILM COATED, EXTENDED RE11
41163-336-01Acetaminophen 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 [SUPERVALU INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-336ACETAMINOPHEN 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUPERVALU INC.]1Legacy NDC, 2 package rows20130905_80c990c4-53f4-4102-b99b-f19bc895e5cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN80c990c4-53f4-4102-b99b-f19bc895e5cb1
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD80c990c4-53f4-4102-b99b-f19bc895e5cb1
11483998 HR APAP 650 MG Extended Release Oral TabletSY80c990c4-53f4-4102-b99b-f19bc895e5cb1
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY80c990c4-53f4-4102-b99b-f19bc895e5cb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
41163-336-01411630336011 in 1 CARTONHistorical