FDA.reportPublic FDA data

Aripiprazole

Product NDC
70518-0970
11-digit product format
705180970
Labeler code
70518
Product ID
70518-0970_48495da3-0a7e-7314-e063-6294a90a5b4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA204838
Marketing category
ANDA
Marketing start
2018-01-22
Substance
ARIPIPRAZOLE
Active strength
5 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
ARIPIPRAZOLE5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui402131

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
915afeb5-0b22-42c0-86ea-77abf1c5fe15Product name120250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6eProduct name120231010
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
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
70518-0970-0Aripiprazole30 in 1 BLISTER PACKTABLET3015
70518-0970-1Aripiprazole30 in 1 BOXTABLET3015
70518-0970-2Aripiprazole1 in 1 POUCHTABLET115
70518-0970-3Aripiprazole180 in 1 BOTTLE, PLASTICTABLET18015

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0970ARIPIPRAZOLE TABLET [REMEDYREPACK INC.]13Current NDC, Legacy NDC, 4 package rows20250504_a1191a90-eb83-4a59-948c-b9774d2c83a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSNa1191a90-eb83-4a59-948c-b9774d2c83a515
402131aripiprazole 5 MG Oral TabletSCDa1191a90-eb83-4a59-948c-b9774d2c83a515

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0970-07051809700030 TABLET in 1 BLISTER PACK (70518-0970-0) 30 tablet2018-01-220000-00-00NoNoCurrent
70518-0970-17051809700130 POUCH in 1 BOX (70518-0970-1) > 1 TABLET in 1 POUCH (70518-0970-2) 30 pouch2019-12-310000-00-00NoNoCurrent
70518-0970-2705180970021 in 1 POUCHHistorical
70518-0970-370518097003180 TABLET in 1 BOTTLE, PLASTIC (70518-0970-3) 180 tablet2023-09-21NoNoCurrent