FDA.reportPublic FDA data

Acetaminophen

Product NDC
53329-643
11-digit product format
533290643
Labeler code
53329
Product ID
53329-643_4f1bbf5a-3e39-3618-e063-6394a90ac6c8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Medline Industries, LP
Application
ANDA076200
Marketing category
ANDA
Marketing start
2002-04-30
Marketing end
2026-12-31
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acetaminophen

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii362O9ITL9D
Rxcui1148399

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-643-29Acetaminophen50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE5010

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-643ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [MEDLINE INDUSTRIES, LP]9Current NDC, Legacy NDC, 1 package rows20250114_9f18d455-55ce-482c-8da8-dcb664038c6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN9f18d455-55ce-482c-8da8-dcb664038c6c10
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD9f18d455-55ce-482c-8da8-dcb664038c6c10
11483998 HR APAP 650 MG Extended Release Oral TabletSY9f18d455-55ce-482c-8da8-dcb664038c6c10
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY9f18d455-55ce-482c-8da8-dcb664038c6c10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53329-643-295332906432950 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (53329-643-29) 2018-07-102026-12-31NoNoCurrent