FDA.reportPublic FDA data

Aripiprazole

Product NDC
50090-4665
11-digit product format
500904665
Labeler code
50090
Product ID
50090-4665_eba98c5b-8c56-4bc5-bfb5-040fdc12ab8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207105
Marketing category
ANDA
Marketing start
2019-02-27
Substance
ARIPIPRAZOLE
Active strength
5 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
ARIPIPRAZOLE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui402131

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
50090-4665-02023-02-07C16284748780-1f386c64a-104a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
50090-4665-12023-02-07C16284748780-1f386c64a-104a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
50090-4665-02023-01-30C16284748780-1f386c64a-104a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
50090-4665-12023-01-30C16284748780-1f386c64a-104a-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4665-0Aripiprazole30 in 1 BOTTLETABLET3011
50090-4665-1Aripiprazole90 in 1 BOTTLETABLET9011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4665-0EA - Each50090-46654ad0f1c1-9e23-4b56-b8ed-52d47aa89aaf12022-12-07
50090-4665-1EA - Each50090-4665d7f8d195-7cdb-4734-accb-65879cc06fe612024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4665ARIPIPRAZOLE TABLET [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 2 package rows20240606_3ab6af7c-3169-46bf-bd3f-697c81bbcede.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSN3ab6af7c-3169-46bf-bd3f-697c81bbcede11
402131aripiprazole 5 MG Oral TabletSCD3ab6af7c-3169-46bf-bd3f-697c81bbcede11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4665-05009046650030 TABLET in 1 BOTTLE (50090-4665-0) 30 tablet2019-10-310000-00-00NoNoCurrent
50090-4665-15009046650190 TABLET in 1 BOTTLE (50090-4665-1) 90 tablet2019-10-310000-00-00NoNoCurrent