Arthritis Pain Reliever

Product NDC
68084-777
11-digit product format
680840777
Labeler code
68084
Product ID
68084-777_e0e00d71-fc23-d450-e053-2a95a90a4f7a
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
American Health Packaging
Application
ANDA076200
Marketing category
ANDA
Marketing start
2014-08-18
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
650 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-777-25EA - Each68084-7771d620eb5-66a2-42e7-8d08-d4e7bf6bb3d012014-10-03
68084-777-95EA - Each68084-77736cfff41-8f8a-4ffb-9d3b-08874ec6d74012014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-777ARTHRITIS PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [AMERICAN HEALTH PACKAGING]8Legacy NDC20241123_ac5b24a4-39a8-4c8a-b293-5f59966fb444.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68084-777-256808407772530 BLISTER PACK in 1 BOX, UNIT-DOSE (68084-777-25) > 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK (68084-777-95) 30 blister pack2014-08-180000-00-00NoNoCurrent