FDA.reportPublic FDA data

Acetaminophen

Product NDC
55319-333
11-digit product format
553190333
Labeler code
55319
Product ID
55319-333_9f6c1828-d7a7-489c-91c4-fd6f4faf2dc8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Family Dollar Services, Inc.
Application
ANDA076200
Marketing category
ANDA
Marketing start
2017-09-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-333-012023-01-30C16284748780-1f386c649-fba5-0266-e053-dadaa90a7c1aAcetaminophen
55319-333-232023-01-30C16284748780-1f386c649-fba5-0266-e053-dadaa90a7c1aAcetaminophen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-333-01Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1008
55319-333-23Acetaminophen24 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE248

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-333ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [FAMILY DOLLAR SERVICES, INC.]8Legacy NDC, 2 package rows20200707_c65ef88a-ec37-4d61-8420-17f4807ac93a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNc65ef88a-ec37-4d61-8420-17f4807ac93a8
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDc65ef88a-ec37-4d61-8420-17f4807ac93a8
11483998 HR APAP 650 MG Extended Release Oral TabletSYc65ef88a-ec37-4d61-8420-17f4807ac93a8
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYc65ef88a-ec37-4d61-8420-17f4807ac93a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55319-333-0155319033301100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55319-333-01) 2019-05-300000-00-00NoNoCurrent
55319-333-235531903332324 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (55319-333-23) 2017-09-010000-00-00NoNoCurrent