mapap arthritis pain

Product NDC
0904-5769
11-digit product format
009045769
Labeler code
0904
Product ID
0904-5769_21078c0d-76b8-4596-9c4e-a9c1f8a84958
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA075077
Marketing category
ANDA
Marketing start
2006-02-16
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
0904-5769-60EA - Each0904-57697e107f1d-fd5a-416f-8fb3-6589ae16877312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
ACETAMINOPHENACTIVE MOIETY362O9ITL9DMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48MAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4MAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-5769MAPAP ARTHRITIS PAIN (ACETAMINOPHEN) TABLET, FILM COATED, EXTENDED RELEASE [MAJOR PHARMACEUTICALS]6Legacy NDC20221111_61f212a4-3748-4782-95ce-5434f931b4f4.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-5769-60009045769601 BOTTLE in 1 CARTON (0904-5769-60) > 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE1 bottle2006-02-160000-00-00NoNoCurrent