FDA.reportPublic FDA data

Aripiprazole

Product NDC
31722-829
11-digit product format
317220829
Labeler code
31722
Product ID
31722-829_10628de5-d649-12ef-e063-6394a90ae380
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205064
Marketing category
ANDA
Marketing start
2015-04-28
Substance
ARIPIPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490, 349545, 349547, 349553, 402131, 602964

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-829-01Aripiprazole100 in 1 BOTTLETABLET10017
31722-829-05Aripiprazole500 in 1 BOTTLETABLET50017
31722-829-30Aripiprazole30 in 1 BOTTLETABLET3017
31722-829-31Aripiprazole10 in 1 BLISTER PACKTABLET1017
31722-829-32Aripiprazole250 in 1 CARTONTABLET25017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-829-30EA - Each31722-829cf6231e3-6e83-45da-a799-3c603673c04512015-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]4
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675ARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJARIPIPRAZOLE TABLET [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-829ARIPIPRAZOLE (ARIPIPRAZOLE) TABLET [CAMBER PHARMACEUTICALS, INC.]17Current NDC, Legacy NDC, 5 package rows20240203_2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349490ARIPiprazole 15 MG Oral TabletPSN2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
602964ARIPiprazole 2 MG Oral TabletPSN2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349553ARIPiprazole 20 MG Oral TabletPSN2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349547ARIPiprazole 30 MG Oral TabletPSN2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
402131ARIPiprazole 5 MG Oral TabletPSN2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349545aripiprazole 10 MG Oral TabletSCD2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349490aripiprazole 15 MG Oral TabletSCD2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
602964aripiprazole 2 MG Oral TabletSCD2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349553aripiprazole 20 MG Oral TabletSCD2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349547aripiprazole 30 MG Oral TabletSCD2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
402131aripiprazole 5 MG Oral TabletSCD2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa17
349545ARIPiprazole 10 MG Oral TabletPSN80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349490ARIPiprazole 15 MG Oral TabletPSN80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
602964ARIPiprazole 2 MG Oral TabletPSN80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349553ARIPiprazole 20 MG Oral TabletPSN80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349547ARIPiprazole 30 MG Oral TabletPSN80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
402131ARIPiprazole 5 MG Oral TabletPSN80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349545aripiprazole 10 MG Oral TabletSCD80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349490aripiprazole 15 MG Oral TabletSCD80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
602964aripiprazole 2 MG Oral TabletSCD80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349553aripiprazole 20 MG Oral TabletSCD80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349547aripiprazole 30 MG Oral TabletSCD80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
402131aripiprazole 5 MG Oral TabletSCD80e079f0-faf5-4c0c-b1a8-9bc3cc2cde009
349545ARIPiprazole 10 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349490ARIPiprazole 15 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
602964ARIPiprazole 2 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349553ARIPiprazole 20 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349547ARIPiprazole 30 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
402131ARIPiprazole 5 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349545aripiprazole 10 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349490aripiprazole 15 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
602964aripiprazole 2 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349553aripiprazole 20 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349547aripiprazole 30 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
402131aripiprazole 5 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
31722-829-0131722082901100 TABLET in 1 BOTTLE (31722-829-01) 100 tablet2015-04-280000-00-00NoNoCurrent
31722-829-0531722082905500 TABLET in 1 BOTTLE (31722-829-05) 500 tablet2024-02-02NoNoHistorical
31722-829-303172208293030 TABLET in 1 BOTTLE (31722-829-30) 30 tablet2015-04-280000-00-00NoNoCurrent
31722-829-313172208293110 TABLET in 1 BLISTER PACK (31722-829-31) 10 tablet2015-04-280000-00-00NoNoCurrent
31722-829-3231722082932250 TABLET in 1 CARTON (31722-829-32) 250 tablet2015-04-280000-00-00NoNoCurrent