ARIPIPRAZOLE

Product NDC
43547-306
11-digit product format
435470306
Labeler code
43547
Product ID
43547-306_1f3b82ac-31e8-481a-adc5-dbfc29362ffd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Solco Healthcare U.S., LLC
Application
ANDA205363
Marketing category
ANDA
Marketing start
2017-12-04
Substance
ARIPIPRAZOLE
Active strength
20 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
ARIPIPRAZOLE20 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
43547-306-03ARIPIPRAZOLE30 in 1 BOTTLETABLET306
43547-306-09ARIPIPRAZOLE90 in 1 BOTTLETABLET906
43547-306-10ARIPIPRAZOLE100 in 1 BOTTLETABLET1006
43547-306-50ARIPIPRAZOLE500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43547-306-03EA - Each43547-3068d0f6315-0e3f-4723-bf47-8aeb98f3707012018-02-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43547-306ARIPIPRAZOLE TABLET [SOLCO HEALTHCARE U.S., LLC]5Current NDC, Legacy NDC, 4 package rows20230411_686d0088-ac61-41df-8909-ae12f7957644.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN686d0088-ac61-41df-8909-ae12f79576446
349490ARIPiprazole 15 MG Oral TabletPSN686d0088-ac61-41df-8909-ae12f79576446
602964ARIPiprazole 2 MG Oral TabletPSN686d0088-ac61-41df-8909-ae12f79576446
349553ARIPiprazole 20 MG Oral TabletPSN686d0088-ac61-41df-8909-ae12f79576446
349547ARIPiprazole 30 MG Oral TabletPSN686d0088-ac61-41df-8909-ae12f79576446
402131ARIPiprazole 5 MG Oral TabletPSN686d0088-ac61-41df-8909-ae12f79576446
349545aripiprazole 10 MG Oral TabletSCD686d0088-ac61-41df-8909-ae12f79576446
349490aripiprazole 15 MG Oral TabletSCD686d0088-ac61-41df-8909-ae12f79576446
602964aripiprazole 2 MG Oral TabletSCD686d0088-ac61-41df-8909-ae12f79576446
349553aripiprazole 20 MG Oral TabletSCD686d0088-ac61-41df-8909-ae12f79576446
349547aripiprazole 30 MG Oral TabletSCD686d0088-ac61-41df-8909-ae12f79576446
402131aripiprazole 5 MG Oral TabletSCD686d0088-ac61-41df-8909-ae12f79576446

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43547-306-034354703060330 TABLET in 1 BOTTLE (43547-306-03) 30 tablet2017-12-040000-00-00NoNoCurrent
43547-306-094354703060990 TABLET in 1 BOTTLE (43547-306-09) 90 tablet2017-12-040000-00-00NoNoCurrent
43547-306-1043547030610100 TABLET in 1 BOTTLE (43547-306-10) 100 tablet2017-12-040000-00-00NoNoCurrent
43547-306-5043547030650500 TABLET in 1 BOTTLE (43547-306-50) 500 tablet2017-12-040000-00-00NoNoCurrent