FDA.reportPublic FDA data

Aripiprazole

Product NDC
70518-2897
11-digit product format
705182897
Labeler code
70518
Product ID
70518-2897_4d65bd57-682e-56be-e063-6294a90a2468
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207105
Marketing category
ANDA
Marketing start
2020-09-28
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
34645f32-2ac4-41bf-9c61-8107e4764a26Product name120181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25dProduct name120180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02Product name120170824
8223ef47-de85-24dd-a9c7-5a041d2634a2Product name920170223

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-2897-02022-02-08C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
70518-2897-02022-02-08C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
70518-2897-02022-02-08C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
70518-2897-02022-02-08C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
70518-2897-02022-01-28C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
70518-2897-02022-01-28C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
70518-2897-02022-01-28C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002
70518-2897-02022-01-28C16284748780-1d6a99b39-9668-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-2897-0Aripiprazole30 in 1 BLISTER PACKTABLET3012
70518-2897-1Aripiprazole30 in 1 BOTTLE, PLASTICTABLET3012
70518-2897-2Aripiprazole180 in 1 BOTTLE, PLASTICTABLET18012
70518-2897-3Aripiprazole30 in 1 BLISTER PACKTABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2897-0EA - Each70518-2897c0f67b6c-95df-4fe0-8293-dc33f5eb17ba12026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2897ARIPIPRAZOLE TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 4 package rows20250507_433cdc7d-465a-4ad4-bd84-cabd37e15f51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSN433cdc7d-465a-4ad4-bd84-cabd37e15f5112
402131aripiprazole 5 MG Oral TabletSCD433cdc7d-465a-4ad4-bd84-cabd37e15f5112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2897-07051828970030 TABLET in 1 BLISTER PACK (70518-2897-0) 30 tablet2020-09-280000-00-00NoNoCurrent
70518-2897-17051828970130 TABLET in 1 BOTTLE, PLASTIC (70518-2897-1) 30 tablet2025-07-01NoNoCurrent
70518-2897-270518289702180 TABLET in 1 BOTTLE, PLASTIC (70518-2897-2) 180 tablet2025-10-16NoNoCurrent
70518-2897-37051828970330 TABLET in 1 BLISTER PACK (70518-2897-3) 30 tablet2026-03-19NoNoCurrent