Sunmark Arthritis 8 Hour

Product NDC
49348-924
11-digit product format
493480924
Labeler code
49348
Product ID
49348-924_579c5e78-3a1a-4b93-b1ad-3d71d83c91f7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Sunmark
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
49348-924-092020-01-31C16284748780-19d75b9d1-0d7d-f424-e053-dadaa90a57ceDrug Facts
49348-924-102020-01-31C16284748780-19d75b9d1-0d7d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-924-09Sunmark Arthritis 8 Hour50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE501
49348-924-10Sunmark Arthritis 8 Hour100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-924-09EA - Each49348-92420bbfe10-c1a5-4644-9fba-a0a4a14cb57e12013-02-13
49348-924-10EA - Each49348-924601fdd47-d845-4143-bbcb-d2c85176eb6f12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ESUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJSUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-924SUNMARK ARTHRITIS 8 HOUR (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]1Legacy NDC, 2 package rows20120817_ab6401f9-9310-40dd-8f15-0d7199e27925.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNab6401f9-9310-40dd-8f15-0d7199e279251
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDab6401f9-9310-40dd-8f15-0d7199e279251
11483998 HR APAP 650 MG Extended Release Oral TabletSYab6401f9-9310-40dd-8f15-0d7199e279251
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYab6401f9-9310-40dd-8f15-0d7199e279251

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49348-924-094934809240950 in 1 BOTTLEHistorical
49348-924-1049348092410100 in 1 BOTTLEHistorical