Aripiprazole

Product NDC
0904-6510
11-digit product format
009046510
Labeler code
0904
Product ID
0904-6510_b57698aa-42fb-43eb-84bc-8c20a358a946
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA078583
Marketing category
ANDA
Marketing start
2015-08-25
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
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
0904-6510-06EA - Each0904-65104b354e05-3b34-4cfd-9830-5b204313b98312018-12-13
0904-6510-61EA - Each0904-65107cfbd88f-bb30-44e7-b5d2-8e2ddc1087dc12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6510ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]7Legacy NDC20240920_3279b9dc-8efd-463b-8f15-e26162ed78e3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6510-060090465100650 BLISTER PACK in 1 CARTON (0904-6510-06) > 1 TABLET in 1 BLISTER PACK50 blister pack2015-08-250000-00-00NoNoCurrent
0904-6510-6100904651061100 BLISTER PACK in 1 CARTON (0904-6510-61) > 1 TABLET in 1 BLISTER PACK100 blister pack2015-08-250000-00-00NoNoCurrent