Arthritis 8 Hour

Product NDC
21130-336
11-digit product format
211300336
Labeler code
21130
Product ID
21130-336_106ff398-7ae3-4eae-bd7d-a8ac2e0254fd
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Safeway Inc.
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
21130-336-012020-01-31C16284748780-19d75b9d0-5b93-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-336-01Arthritis 8 Hour100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-336ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SAFEWAY INC.]1Legacy NDC, 1 package rows20120927_67b2b4c0-4a2f-4952-8a88-3616d0185941.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSN67b2b4c0-4a2f-4952-8a88-3616d01859411
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCD67b2b4c0-4a2f-4952-8a88-3616d01859411
11483998 HR APAP 650 MG Extended Release Oral TabletSY67b2b4c0-4a2f-4952-8a88-3616d01859411
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSY67b2b4c0-4a2f-4952-8a88-3616d01859411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21130-336-0121130033601100 in 1 BOTTLEHistorical