Acetaminophen

Product NDC
37808-333
11-digit product format
378080333
Labeler code
37808
Product ID
37808-333_a67ea2d8-b415-4468-9e7a-bae4172428a0
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, EXTENDED RELEASE
Route
ORAL
Labeler
H-E-B
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
37808-333-012020-01-31C16284748780-19d75b9d0-3a96-f424-e053-dadaa90a57ceDrug Facts
37808-333-502020-01-31C16284748780-19d75b9d0-3a96-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-333-01Acetaminophen100 in 1 BOTTLETABLET, EXTENDED RELEASE1001
37808-333-50Acetaminophen1 in 1 CARTONTABLET, EXTENDED RELEASE11
37808-333-50Acetaminophen50 in 1 BOTTLETABLET, EXTENDED RELEASE501

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-333ACETAMINOPHEN TABLET, EXTENDED RELEASE [H-E-B]1Legacy NDC, 3 package rows20141125_a67ea2d8-b415-4468-9e7a-bae4172428a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNa67ea2d8-b415-4468-9e7a-bae4172428a01
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDa67ea2d8-b415-4468-9e7a-bae4172428a01
11483998 HR APAP 650 MG Extended Release Oral TabletSYa67ea2d8-b415-4468-9e7a-bae4172428a01
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYa67ea2d8-b415-4468-9e7a-bae4172428a01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
37808-333-0137808033301100 in 1 BOTTLEHistorical
37808-333-50378080333501 in 1 CARTONHistorical