Acetaminophen

Product NDC
37012-333
11-digit product format
370120333
Labeler code
37012
Product ID
37012-333_74d80c8c-fd10-4aac-9fbf-0821d434f28a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Shopko Stores Operating Co., LLC
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
37012-333-012020-01-31C16284748780-19d75b9d0-dfb4-f424-e053-dadaa90a57ceDrug Facts
37012-333-042020-01-31C16284748780-19d75b9d0-dfb4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37012-333-01Acetaminophen100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001
37012-333-04Acetaminophen250 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE2501

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37012-333ACETAMINOPHEN TABLET, FILM COATED, EXTENDED RELEASE [SHOPKO STORES OPERATING CO., LLC]1Legacy NDC, 2 package rows20130325_5f564d84-7a62-4d84-af94-3262c707269f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN5f564d84-7a62-4d84-af94-3262c707269f1
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD5f564d84-7a62-4d84-af94-3262c707269f1
11483998 HR APAP 650 MG Extended Release Oral TabletSY5f564d84-7a62-4d84-af94-3262c707269f1
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY5f564d84-7a62-4d84-af94-3262c707269f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
37012-333-0137012033301100 in 1 BOTTLEHistorical
37012-333-0437012033304250 in 1 BOTTLEHistorical