FDA.reportPublic FDA data

Acetaminophen

Product NDC
62011-0026
11-digit product format
620110026
Labeler code
62011
Product ID
62011-0026_3e52d202-a199-4cfc-bed2-86c24af8a61b
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Health Mart
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
62011-0026-12020-01-31C16284748780-19d75b9cf-f9c5-f424-e053-dadaa90a57ceArthritis Pain Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62011-0026-1Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0026-1EA - Each62011-0026b5759e31-8dcb-4727-a0d4-0b74f7146e2a12013-02-13

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0026ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [HEALTH MART]2Legacy NDC, 1 package rows20180509_b8373c83-6e2a-4dec-a242-e442b9653ff5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNb8373c83-6e2a-4dec-a242-e442b9653ff52
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDb8373c83-6e2a-4dec-a242-e442b9653ff52
11483998 HR APAP 650 MG Extended Release Oral TabletSYb8373c83-6e2a-4dec-a242-e442b9653ff52
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYb8373c83-6e2a-4dec-a242-e442b9653ff52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
62011-0026-162011002601100 in 1 BOTTLEHistorical