FDA.reportPublic FDA data

Aripiprazole

Product NDC
62332-102
11-digit product format
623320102
Labeler code
62332
Product ID
62332-102_27cb5061-f64f-4328-9d1e-c18250dcb23a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA202101
Marketing category
ANDA
Marketing start
2016-07-07
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
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
62332-102-10Aripiprazole100 in 1 CARTONTABLET10019
62332-102-30Aripiprazole30 in 1 BOTTLETABLET3019
62332-102-31Aripiprazole100 in 1 BOTTLETABLET10019
62332-102-71Aripiprazole500 in 1 BOTTLETABLET50019
62332-102-91Aripiprazole1000 in 1 BOTTLETABLET100019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-102-30EA - Each62332-102f573cc76-cdaa-47fa-9827-dc734e29f14e12017-05-04
62332-102-31EA - Each62332-1020abca0ed-9a6a-4fc1-92bf-301d3970c42912017-05-04
62332-102-71EA - Each62332-102ba064658-64f4-48ad-903e-4adb8d0dd9d812024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-102ARIPIPRAZOLE TABLET [ALEMBIC PHARMACEUTICALS INC.]18Current NDC, Legacy NDC, 5 package rows20250523_a10a5427-58b1-42dd-964c-3f8c78770534.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSNa10a5427-58b1-42dd-964c-3f8c7877053419
349490ARIPiprazole 15 MG Oral TabletPSNa10a5427-58b1-42dd-964c-3f8c7877053419
602964ARIPiprazole 2 MG Oral TabletPSNa10a5427-58b1-42dd-964c-3f8c7877053419
349553ARIPiprazole 20 MG Oral TabletPSNa10a5427-58b1-42dd-964c-3f8c7877053419
349547ARIPiprazole 30 MG Oral TabletPSNa10a5427-58b1-42dd-964c-3f8c7877053419
402131ARIPiprazole 5 MG Oral TabletPSNa10a5427-58b1-42dd-964c-3f8c7877053419
349545aripiprazole 10 MG Oral TabletSCDa10a5427-58b1-42dd-964c-3f8c7877053419
349490aripiprazole 15 MG Oral TabletSCDa10a5427-58b1-42dd-964c-3f8c7877053419
602964aripiprazole 2 MG Oral TabletSCDa10a5427-58b1-42dd-964c-3f8c7877053419
349553aripiprazole 20 MG Oral TabletSCDa10a5427-58b1-42dd-964c-3f8c7877053419
349547aripiprazole 30 MG Oral TabletSCDa10a5427-58b1-42dd-964c-3f8c7877053419
402131aripiprazole 5 MG Oral TabletSCDa10a5427-58b1-42dd-964c-3f8c7877053419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-102-1062332010210100 TABLET in 1 CARTON (62332-102-10) 100 tablet2016-07-070000-00-00NoNoCurrent
62332-102-306233201023030 TABLET in 1 BOTTLE (62332-102-30) 30 tablet2016-07-070000-00-00NoNoCurrent
62332-102-3162332010231100 TABLET in 1 BOTTLE (62332-102-31) 100 tablet2016-07-070000-00-00NoNoCurrent
62332-102-7162332010271500 TABLET in 1 BOTTLE (62332-102-71) 500 tablet2016-07-070000-00-00NoNoCurrent
62332-102-91623320102911000 TABLET in 1 BOTTLE (62332-102-91) 1000 tablet2016-07-070000-00-00NoNoCurrent