FDA.reportPublic FDA data

Aripiprazole

Product NDC
63629-7774
11-digit product format
636297774
Labeler code
63629
Product ID
63629-7774_392861a2-8af9-4918-ba39-00e68ca3bb3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204838
Marketing category
ANDA
Marketing start
2016-06-20
Substance
ARIPIPRAZOLE
Active strength
30 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
ARIPIPRAZOLE30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349547

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
63629-7774-12024-05-14C16284748780-19d75b9d0-0b9b-f424-e053-dadaa90a57ceThese 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
63629-7774-12024-01-30C16284748780-19d75b9d0-0b9b-f424-e053-dadaa90a57ceThese 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
63629-7774-12020-10-12C16284748780-19d75b9d0-0b9b-f424-e053-dadaa90a57ceThese 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
63629-7774-12020-01-31C16284748780-19d75b9d0-0b9b-f424-e053-dadaa90a57ceThese 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
63629-7774-1Aripiprazole30 in 1 BOTTLETABLET306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-7774ARIPIPRAZOLE TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 1 package rows20240516_96172aa4-9e13-4eca-83d5-85a88c1782d3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349547ARIPiprazole 30 MG Oral TabletPSN96172aa4-9e13-4eca-83d5-85a88c1782d36
349547aripiprazole 30 MG Oral TabletSCD96172aa4-9e13-4eca-83d5-85a88c1782d36

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-7774-16362977740130 TABLET in 1 BOTTLE (63629-7774-1) 30 tablet2018-07-030000-00-00NoNoCurrent