FDA.reportPublic FDA data

aripiprazole

Product NDC
13668-216
11-digit product format
136680216
Labeler code
13668
Product ID
13668-216_264dc32a-9f5f-43be-96ee-0d30503de683
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA201519
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13668-216-01aripiprazole100 in 1 BOTTLETABLET10017
13668-216-05aripiprazole500 in 1 BOTTLETABLET50017
13668-216-30aripiprazole30 in 1 BOTTLETABLET3017
13668-216-69aripiprazole6250 in 1 BOTTLETABLET625017
13668-216-90aripiprazole90 in 1 BOTTLETABLET9017

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-216-05EA - Each13668-216866c03c4-19c6-4827-a3a0-3afcb5554e9c12017-08-11
13668-216-30EA - Each13668-2168bcf83fd-b30d-4395-8fae-b75441a5c67812015-06-09
13668-216-90EA - Each13668-216c0e7a1e4-c419-49f8-a5fc-c6d596aa7b8312015-06-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ARIPIPRAZOLEACTIVE INGREDIENT82VFR53I78ARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
ARIPIPRAZOLEACTIVE MOIETY82VFR53I78ARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
HYDROXYPROPYL CELLULOSE (TYPE H)INACTIVE INGREDIENTRFW2ET671PARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1
MANNITOLINACTIVE INGREDIENT3OWL53L36AARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-216ARIPIPRAZOLE TABLET [TORRENT PHARMACEUTICALS LIMITED]17Current NDC, Legacy NDC, 5 package rows20250423_3988e66f-339c-451e-9f8a-9d0c0a2a381b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN3988e66f-339c-451e-9f8a-9d0c0a2a381b17
349490ARIPiprazole 15 MG Oral TabletPSN3988e66f-339c-451e-9f8a-9d0c0a2a381b17
602964ARIPiprazole 2 MG Oral TabletPSN3988e66f-339c-451e-9f8a-9d0c0a2a381b17
349553ARIPiprazole 20 MG Oral TabletPSN3988e66f-339c-451e-9f8a-9d0c0a2a381b17
349547ARIPiprazole 30 MG Oral TabletPSN3988e66f-339c-451e-9f8a-9d0c0a2a381b17
402131ARIPiprazole 5 MG Oral TabletPSN3988e66f-339c-451e-9f8a-9d0c0a2a381b17
349545aripiprazole 10 MG Oral TabletSCD3988e66f-339c-451e-9f8a-9d0c0a2a381b17
349490aripiprazole 15 MG Oral TabletSCD3988e66f-339c-451e-9f8a-9d0c0a2a381b17
602964aripiprazole 2 MG Oral TabletSCD3988e66f-339c-451e-9f8a-9d0c0a2a381b17
349553aripiprazole 20 MG Oral TabletSCD3988e66f-339c-451e-9f8a-9d0c0a2a381b17
349547aripiprazole 30 MG Oral TabletSCD3988e66f-339c-451e-9f8a-9d0c0a2a381b17
402131aripiprazole 5 MG Oral TabletSCD3988e66f-339c-451e-9f8a-9d0c0a2a381b17
602964ARIPiprazole 2 MG Oral TabletPSN1ad7d167-1235-4c5c-8159-da8972240ede9
602964aripiprazole 2 MG Oral TabletSCD1ad7d167-1235-4c5c-8159-da8972240ede9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-216-0113668021601100 TABLET in 1 BOTTLE (13668-216-01) 100 tablet2015-04-280000-00-00NoNoCurrent
13668-216-0513668021605500 TABLET in 1 BOTTLE (13668-216-05) 500 tablet2015-04-280000-00-00NoNoCurrent
13668-216-301366802163030 TABLET in 1 BOTTLE (13668-216-30) 30 tablet2015-04-280000-00-00NoNoCurrent
13668-216-69136680216696250 TABLET in 1 BOTTLE (13668-216-69) 6250 tablet2015-04-280000-00-00NoNoCurrent
13668-216-7413668021674100 TABLET in 1 CARTON (13668-216-74) 100 tablet2015-04-280000-00-00NoNoCurrent
13668-216-901366802169090 TABLET in 1 BOTTLE (13668-216-90) 90 tablet2015-04-280000-00-00NoNoCurrent