FDA.reportPublic FDA data

Aripiprazole

Product NDC
33342-127
11-digit product format
333420127
Labeler code
33342
Product ID
33342-127_deb9183f-bf62-4547-9c33-b6d8af55ddd9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204111
Marketing category
ANDA
Marketing start
2016-10-08
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
33342-127-07Aripiprazole30 in 1 BOTTLETABLET309
33342-127-11Aripiprazole100 in 1 BOTTLETABLET1009
33342-127-12Aripiprazole10 in 1 BLISTER PACKTABLET109
33342-127-12Aripiprazole10 in 1 CARTONTABLET109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-127-07EA - Each33342-127cbd42c1d-dbf6-4e95-ac55-fd1cbe7c041312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-127ARIPIPRAZOLE TABLET [MACLEODS PHARMACEUTICALS LIMITED]9Current NDC, Legacy NDC, 4 package rows20250327_ab4245a1-71f7-45be-a2ef-b0636ed3cc20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSNab4245a1-71f7-45be-a2ef-b0636ed3cc209
349490ARIPiprazole 15 MG Oral TabletPSNab4245a1-71f7-45be-a2ef-b0636ed3cc209
602964ARIPiprazole 2 MG Oral TabletPSNab4245a1-71f7-45be-a2ef-b0636ed3cc209
349553ARIPiprazole 20 MG Oral TabletPSNab4245a1-71f7-45be-a2ef-b0636ed3cc209
349547ARIPiprazole 30 MG Oral TabletPSNab4245a1-71f7-45be-a2ef-b0636ed3cc209
402131ARIPiprazole 5 MG Oral TabletPSNab4245a1-71f7-45be-a2ef-b0636ed3cc209
349545aripiprazole 10 MG Oral TabletSCDab4245a1-71f7-45be-a2ef-b0636ed3cc209
349490aripiprazole 15 MG Oral TabletSCDab4245a1-71f7-45be-a2ef-b0636ed3cc209
602964aripiprazole 2 MG Oral TabletSCDab4245a1-71f7-45be-a2ef-b0636ed3cc209
349553aripiprazole 20 MG Oral TabletSCDab4245a1-71f7-45be-a2ef-b0636ed3cc209
349547aripiprazole 30 MG Oral TabletSCDab4245a1-71f7-45be-a2ef-b0636ed3cc209
402131aripiprazole 5 MG Oral TabletSCDab4245a1-71f7-45be-a2ef-b0636ed3cc209

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-127-073334201270730 TABLET in 1 BOTTLE (33342-127-07) 30 tablet2016-10-080000-00-00NoNoCurrent
33342-127-1133342012711100 TABLET in 1 BOTTLE (33342-127-11) 100 tablet2016-10-080000-00-00NoNoCurrent
33342-127-123334201271210 BLISTER PACK in 1 CARTON (33342-127-12) / 10 TABLET in 1 BLISTER PACK10 blister pack2016-10-080000-00-00NoNoCurrent