FDA.reportPublic FDA data

Aripiprazole

Product NDC
50090-4936
11-digit product format
500904936
Labeler code
50090
Product ID
50090-4936_4e29d321-b967-427a-ba5b-a7959fcb08e8
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
10 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349545

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
50090-4936-02024-08-06C16284748780-1f386c649-b120-0266-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
50090-4936-12024-08-06C16284748780-1f386c649-b120-0266-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
50090-4936-02023-01-30C16284748780-1f386c649-b120-0266-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
50090-4936-12023-01-30C16284748780-1f386c649-b120-0266-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
50090-4936-0Aripiprazole90 in 1 BOTTLETABLET907
50090-4936-1Aripiprazole30 in 1 BOTTLETABLET307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-4936-1EA - Each50090-493681949ede-6afa-477e-a865-8c6bd05af77212024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4936ARIPIPRAZOLE TABLET [A-S MEDICATION SOLUTIONS]5Current NDC, Legacy NDC, 2 package rows20240808_554db933-aa80-4685-bcd5-58c84571c19c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN554db933-aa80-4685-bcd5-58c84571c19c7
349545aripiprazole 10 MG Oral TabletSCD554db933-aa80-4685-bcd5-58c84571c19c7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4936-05009049360090 TABLET in 1 BOTTLE (50090-4936-0) 90 tablet2020-02-270000-00-00NoNoCurrent
50090-4936-15009049360130 TABLET in 1 BOTTLE (50090-4936-1) 30 tablet2020-02-270000-00-00NoNoCurrent