FDA.reportPublic FDA data

aripiprazole

Product NDC
70518-2584
11-digit product format
705182584
Labeler code
70518
Product ID
70518-2584_4a693488-7f64-7b60-e063-6394a90aa196
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA201519
Marketing category
ANDA
Marketing start
2020-02-17
Substance
ARIPIPRAZOLE
Active strength
2 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
aripiprazole
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui602964

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2584-0aripiprazole30 in 1 BLISTER PACKTABLET309
70518-2584-1aripiprazole180 in 1 BOTTLE, PLASTICTABLET1809
70518-2584-2aripiprazole100 in 1 BOXTABLET1009
70518-2584-3aripiprazole1 in 1 POUCHTABLET19
70518-2584-4aripiprazole30 in 1 BLISTER PACKTABLET309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2584-0EA - Each70518-258408f32e65-28be-4d6d-8768-5b31f39f95b612023-01-09
70518-2584-1EA - Each70518-25844290998a-d009-4529-a957-021aa899d63712023-01-09

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
602964ARIPiprazole 2 MG Oral TabletPSN1ad7d167-1235-4c5c-8159-da8972240ede9
602964aripiprazole 2 MG Oral TabletSCD1ad7d167-1235-4c5c-8159-da8972240ede9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2584-07051825840030 TABLET in 1 BLISTER PACK (70518-2584-0) 30 tablet2020-02-170000-00-00NoNoCurrent
70518-2584-170518258401180 TABLET in 1 BOTTLE, PLASTIC (70518-2584-1) 180 tablet2021-06-070000-00-00NoNoCurrent
70518-2584-270518258402100 in 1 BOXHistorical
70518-2584-3705182584031 in 1 POUCHHistorical
70518-2584-47051825840430 TABLET in 1 BLISTER PACK (70518-2584-4) 30 tablet2025-12-09NoNoHistorical