Sunmark Arthritis Pain Reliever

Product NDC
49348-921
11-digit product format
493480921
Labeler code
49348
Product ID
49348-921_ebc79b1d-d574-43e1-80f8-86bb904bdd8a
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
49348-921-092020-01-31C16284748780-19d75b9d0-8812-f424-e053-dadaa90a57ceDrug Facts
49348-921-102020-01-31C16284748780-19d75b9d0-8812-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49348-921-09Sunmark Arthritis Pain Reliever50 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE502
49348-921-10Sunmark Arthritis Pain Reliever100 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE1002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49348-921-09EA - Each49348-9218d67566e-3b1b-4d4e-ae48-76c46c7690bb12013-02-13
49348-921-10EA - Each49348-92167f92f5d-67ca-4949-ba19-3cb79cf8f60a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DSUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
ACETAMINOPHENACTIVE MOIETY362O9ITL9DSUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ESUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3SUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JSUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJSUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APSUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49348-921SUNMARK ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [SUNMARK]2Legacy NDC, 2 package rows20120820_de777010-7f61-4ee1-96a8-4c9bc3b6c514.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148399acetaminophen 650 MG 8HR Extended Release Oral TabletPSNde777010-7f61-4ee1-96a8-4c9bc3b6c5142
11483998 HR acetaminophen 650 MG Extended Release Oral TabletSCDde777010-7f61-4ee1-96a8-4c9bc3b6c5142
11483998 HR APAP 650 MG Extended Release Oral TabletSYde777010-7f61-4ee1-96a8-4c9bc3b6c5142
1148399acetaminophen 650 MG 8 HR Extended Release Oral TabletSYde777010-7f61-4ee1-96a8-4c9bc3b6c5142

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
49348-921-094934809210950 in 1 BOTTLEHistorical
49348-921-1049348092110100 in 1 BOTTLEHistorical