FDA.reportPublic FDA data

Aripiprazole

Product NDC
67877-435
11-digit product format
678770435
Labeler code
67877
Product ID
67877-435_583fc581-09d7-4d4f-a079-08ba9d00f775
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA207105
Marketing category
ANDA
Marketing start
2019-02-27
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
67877-435-01Aripiprazole100 in 1 BOTTLETABLET10026
67877-435-03Aripiprazole30 in 1 BOTTLETABLET3026
67877-435-05Aripiprazole500 in 1 BOTTLETABLET50026
67877-435-33Aripiprazole10 in 1 BLISTER PACKTABLET1026
67877-435-38Aripiprazole10 in 1 CARTONTABLET1026

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-435ARIPIPRAZOLE TABLET [ASCEND LABORATORIES, LLC]24Current NDC, Legacy NDC, 5 package rows20240229_c7040fef-96a7-4429-9a8e-ec3ab17a8019.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSNc7040fef-96a7-4429-9a8e-ec3ab17a801926
349490ARIPiprazole 15 MG Oral TabletPSNc7040fef-96a7-4429-9a8e-ec3ab17a801926
602964ARIPiprazole 2 MG Oral TabletPSNc7040fef-96a7-4429-9a8e-ec3ab17a801926
349553ARIPiprazole 20 MG Oral TabletPSNc7040fef-96a7-4429-9a8e-ec3ab17a801926
349547ARIPiprazole 30 MG Oral TabletPSNc7040fef-96a7-4429-9a8e-ec3ab17a801926
402131ARIPiprazole 5 MG Oral TabletPSNc7040fef-96a7-4429-9a8e-ec3ab17a801926
349545aripiprazole 10 MG Oral TabletSCDc7040fef-96a7-4429-9a8e-ec3ab17a801926
349490aripiprazole 15 MG Oral TabletSCDc7040fef-96a7-4429-9a8e-ec3ab17a801926
602964aripiprazole 2 MG Oral TabletSCDc7040fef-96a7-4429-9a8e-ec3ab17a801926
349553aripiprazole 20 MG Oral TabletSCDc7040fef-96a7-4429-9a8e-ec3ab17a801926
349547aripiprazole 30 MG Oral TabletSCDc7040fef-96a7-4429-9a8e-ec3ab17a801926
402131aripiprazole 5 MG Oral TabletSCDc7040fef-96a7-4429-9a8e-ec3ab17a801926
349547ARIPiprazole 30 MG Oral TabletPSN1d593ada-256d-4dec-9a26-2a6a67d9720512
349547aripiprazole 30 MG Oral TabletSCD1d593ada-256d-4dec-9a26-2a6a67d9720512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-435-0167877043501100 TABLET in 1 BOTTLE (67877-435-01) 100 tablet2019-02-270000-00-00NoNoCurrent
67877-435-036787704350330 TABLET in 1 BOTTLE (67877-435-03) 30 tablet2019-02-270000-00-00NoNoCurrent
67877-435-0567877043505500 TABLET in 1 BOTTLE (67877-435-05) 500 tablet2019-02-270000-00-00NoNoCurrent
67877-435-336787704353310 in 1 BLISTER PACKHistorical
67877-435-386787704353810 BLISTER PACK in 1 CARTON (67877-435-38) / 10 TABLET in 1 BLISTER PACK (67877-435-33) 10 blister pack2019-02-270000-00-00NoNoCurrent