FDA.reportPublic FDA data

Aripiprazole

Product NDC
46708-254
11-digit product format
467080254
Labeler code
46708
Product ID
46708-254_5108607e-5633-4b19-82f9-6c48720960c4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA202101
Marketing category
ANDA
Marketing start
2015-04-28
Substance
ARIPIPRAZOLE
Active strength
2 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
ARIPIPRAZOLE2 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46708-254-102023-02-01C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-302023-02-01C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-312023-02-01C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-452023-02-01C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-602023-02-01C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-712023-02-01C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-912023-02-01C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-102023-01-30C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-302023-01-30C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-312023-01-30C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-452023-01-30C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-602023-01-30C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-712023-01-30C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002
46708-254-912023-01-30C16284748780-1f386c64a-3460-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use aripiprazole safely and effectively. See full prescribing information for aripiprazole. ARIPIPRAZOLE tablets, for oral use. Initial U.S. Approval : 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-254-10Aripiprazole100 in 1 CARTONTABLET1003
46708-254-30Aripiprazole30 in 1 BOTTLETABLET303
46708-254-31Aripiprazole100 in 1 BOTTLETABLET1003
46708-254-45Aripiprazole180 in 1 BOTTLETABLET1803
46708-254-60Aripiprazole60 in 1 BOTTLETABLET603
46708-254-71Aripiprazole500 in 1 BOTTLETABLET5003
46708-254-91Aripiprazole1000 in 1 BOTTLETABLET10003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-254ARIPIPRAZOLE TABLET [ALEMBIC PHARMACEUTICALS LIMITED]3Current NDC, Legacy NDC, 7 package rows20230202_793fc904-2f11-4f97-a0ac-4d6910cac0f9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349490ARIPiprazole 15 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
602964ARIPiprazole 2 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349553ARIPiprazole 20 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349547ARIPiprazole 30 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
402131ARIPiprazole 5 MG Oral TabletPSN793fc904-2f11-4f97-a0ac-4d6910cac0f93
349545aripiprazole 10 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
349490aripiprazole 15 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
602964aripiprazole 2 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
349553aripiprazole 20 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
349547aripiprazole 30 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93
402131aripiprazole 5 MG Oral TabletSCD793fc904-2f11-4f97-a0ac-4d6910cac0f93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
46708-254-1046708025410100 TABLET in 1 CARTON (46708-254-10) 100 tablet2015-04-280000-00-00NoNoCurrent
46708-254-304670802543030 TABLET in 1 BOTTLE (46708-254-30) 30 tablet2015-04-280000-00-00NoNoCurrent
46708-254-3146708025431100 TABLET in 1 BOTTLE (46708-254-31) 100 tablet2015-04-280000-00-00NoNoCurrent
46708-254-4546708025445180 TABLET in 1 BOTTLE (46708-254-45) 180 tablet2015-04-280000-00-00NoNoCurrent
46708-254-604670802546060 TABLET in 1 BOTTLE (46708-254-60) 60 tablet2015-04-280000-00-00NoNoCurrent
46708-254-7146708025471500 TABLET in 1 BOTTLE (46708-254-71) 500 tablet2015-04-280000-00-00NoNoCurrent
46708-254-91467080254911000 TABLET in 1 BOTTLE (46708-254-91) 1000 tablet2015-04-280000-00-00NoNoCurrent