FDA.reportPublic FDA data

Aripiprazole

Product NDC
70518-2869
11-digit product format
705182869
Labeler code
70518
Product ID
70518-2869_4ab7ef0d-f297-8c9b-e063-6394a90ac6aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA207105
Marketing category
ANDA
Marketing start
2020-09-08
Substance
ARIPIPRAZOLE
Active strength
15 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
ARIPIPRAZOLE15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82VFR53I78
Rxcui349490

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
70518-2869-02022-02-08C16284748780-1d6a99b39-cb7a-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
70518-2869-02022-02-08C16284748780-1d6a99b39-cb7a-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
70518-2869-12022-02-08C16284748780-1d6a99b39-cb7a-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
70518-2869-12022-02-08C16284748780-1d6a99b39-cb7a-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
70518-2869-02022-01-28C16284748780-1d6a99b39-cb7a-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
70518-2869-02022-01-28C16284748780-1d6a99b39-cb7a-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
70518-2869-12022-01-28C16284748780-1d6a99b39-cb7a-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
70518-2869-12022-01-28C16284748780-1d6a99b39-cb7a-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
70518-2869-0Aripiprazole30 in 1 BLISTER PACKTABLET3011
70518-2869-1Aripiprazole30 in 1 BOXTABLET3011
70518-2869-2Aripiprazole1 in 1 POUCHTABLET111

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2869-0EA - Each70518-2869e13bc598-0b22-40c7-807c-789db9c9b7ca12023-01-09
70518-2869-1EA - Each70518-286907bc493c-48a2-40eb-8fbb-2c49aac7a49212023-01-09
70518-2869-2EA - Each70518-2869ea240d75-6597-41af-a392-db13432b01de12023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2869ARIPIPRAZOLE TABLET [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 3 package rows20250503_bc3fde41-2f24-44e2-815d-15fe55bd68b3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349490ARIPiprazole 15 MG Oral TabletPSNbc3fde41-2f24-44e2-815d-15fe55bd68b311
349490aripiprazole 15 MG Oral TabletSCDbc3fde41-2f24-44e2-815d-15fe55bd68b311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2869-07051828690030 TABLET in 1 BLISTER PACK (70518-2869-0) 30 tablet2020-09-080000-00-00NoNoCurrent
70518-2869-17051828690130 POUCH in 1 BOX (70518-2869-1) > 1 TABLET in 1 POUCH (70518-2869-2) 30 pouch2020-10-060000-00-00NoNoCurrent
70518-2869-2705182869021 in 1 POUCHHistorical