FDA.reportPublic FDA data

Aripiprazole

Product NDC
43598-970
11-digit product format
435980970
Labeler code
43598
Product ID
43598-970_5be74c47-c62f-40f5-8aad-bd20f8f4cae3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Dr.Reddy�s Laboratories Inc
Application
ANDA206383
Marketing category
ANDA
Marketing start
2020-03-16
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
43598-970-05Aripiprazole500 in 1 BOTTLETABLET5005
43598-970-30Aripiprazole30 in 1 BOTTLETABLET305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-970ARIPIPRAZOLE TABLET [DR.REDDY’S LABORATORIES INC]4Current NDC, Legacy NDC, 2 package rows20240731_178f09f0-e08e-452b-b817-717c5c49e110.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN178f09f0-e08e-452b-b817-717c5c49e1105
349490ARIPiprazole 15 MG Oral TabletPSN178f09f0-e08e-452b-b817-717c5c49e1105
602964ARIPiprazole 2 MG Oral TabletPSN178f09f0-e08e-452b-b817-717c5c49e1105
349553ARIPiprazole 20 MG Oral TabletPSN178f09f0-e08e-452b-b817-717c5c49e1105
349547ARIPiprazole 30 MG Oral TabletPSN178f09f0-e08e-452b-b817-717c5c49e1105
402131ARIPiprazole 5 MG Oral TabletPSN178f09f0-e08e-452b-b817-717c5c49e1105
349545aripiprazole 10 MG Oral TabletSCD178f09f0-e08e-452b-b817-717c5c49e1105
349490aripiprazole 15 MG Oral TabletSCD178f09f0-e08e-452b-b817-717c5c49e1105
602964aripiprazole 2 MG Oral TabletSCD178f09f0-e08e-452b-b817-717c5c49e1105
349553aripiprazole 20 MG Oral TabletSCD178f09f0-e08e-452b-b817-717c5c49e1105
349547aripiprazole 30 MG Oral TabletSCD178f09f0-e08e-452b-b817-717c5c49e1105
402131aripiprazole 5 MG Oral TabletSCD178f09f0-e08e-452b-b817-717c5c49e1105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43598-970-0543598097005500 TABLET in 1 BOTTLE (43598-970-05) 500 tablet2020-03-160000-00-00NoNoCurrent
43598-970-304359809703030 TABLET in 1 BOTTLE (43598-970-30) 30 tablet2020-03-160000-00-00NoNoCurrent