Aripiprazole

Product NDC
17856-0684
11-digit product format
178560684
Labeler code
17856
Product ID
17856-0684_6f744c80-5232-41f6-abad-a81976e0b1f9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole oral
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA216150
Marketing category
ANDA
Marketing start
2023-11-01
Substance
ARIPIPRAZOLE
Active strength
1 mg/mL
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
ARIPIPRAZOLE1 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui485496

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
17856-0684-1Aripiprazole72 in 1 BOX, UNIT-DOSESOLUTION721
17856-0684-2Aripiprazole72 in 1 BOX, UNIT-DOSESOLUTION721
17856-0684-3Aripiprazole5 mL in 1 CUP, UNIT-DOSESOLUTION51
17856-0684-4Aripiprazole10 mL in 1 CUP, UNIT-DOSESOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0684ARIPIPRAZOLE (ARIPIPRAZOLE ORAL) SOLUTION [ATLANTIC BIOLOGICALS CORP.]1Current NDC, 4 package rows20250130_042b725c-1c17-4cfb-80b2-c841226d795e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSN042b725c-1c17-4cfb-80b2-c841226d795e1
485496aripiprazole 1 MG/ML Oral SolutionSCD042b725c-1c17-4cfb-80b2-c841226d795e1
485496aripiprazole 1 MG per 1 ML Oral SolutionSY042b725c-1c17-4cfb-80b2-c841226d795e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
17856-0684-11785606840172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-1) / 5 mL in 1 CUP, UNIT-DOSE (17856-0684-3) 2025-01-29NoNoCurrent
17856-0684-21785606840272 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0684-2) / 10 mL in 1 CUP, UNIT-DOSE (17856-0684-4) 2025-01-29NoNoCurrent
17856-0684-3178560684035 mL in 1 CUP, UNIT-DOSE5 mlHistorical
17856-0684-41785606840410 mL in 1 CUP, UNIT-DOSE10 mlHistorical