FDA.reportPublic FDA data

Aripiprazole

Product NDC
54838-570
11-digit product format
548380570
Labeler code
54838
Product ID
54838-570_de0ee6f0-d4d7-4d86-9ff9-3ee2c687fccc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
SOLUTION
Route
ORAL
Labeler
Lannett Company, Inc.
Application
ANDA204171
Marketing category
ANDA
Marketing start
2015-08-17
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
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
54838-570-59Aripiprazole150 mL in 1 BOTTLE, PLASTICSOLUTION15028
54838-570-70Aripiprazole237 mL in 1 BOTTLE, PLASTICSOLUTION23728

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54838-570ARIPIPRAZOLE SOLUTION [LANNETT COMPANY, INC.]27Current NDC, Legacy NDC, 2 package rows20250130_e7292c4c-e332-4ed4-9086-f130d223b6ae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSNe7292c4c-e332-4ed4-9086-f130d223b6ae28
485496aripiprazole 1 MG/ML Oral SolutionSCDe7292c4c-e332-4ed4-9086-f130d223b6ae28
485496aripiprazole 1 MG per 1 ML Oral SolutionSYe7292c4c-e332-4ed4-9086-f130d223b6ae28
485496ARIPiprazole 1 MG in 1 mL Oral SolutionPSNdc7ca387-4f62-404c-86b6-d18cdb5740863
485496aripiprazole 1 MG/ML Oral SolutionSCDdc7ca387-4f62-404c-86b6-d18cdb5740863
485496aripiprazole 1 MG per 1 ML Oral SolutionSYdc7ca387-4f62-404c-86b6-d18cdb5740863

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54838-570-5954838057059150 mL in 1 BOTTLE, PLASTIC (54838-570-59) 150 ml2015-08-170000-00-00NoNoCurrent
54838-570-7054838057070237 mL in 1 BOTTLE, PLASTIC (54838-570-70) 237 ml2015-08-170000-00-00NoNoCurrent