ARIPIPRAZOLE

Product NDC
70934-662
Requested package NDC
70934-662-30
11-digit product format
709340662
Labeler code
70934
Product ID
70934-662_aa6ad3de-a5ed-575c-e053-2a95a90a1336
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. dba Northwind Pharmaceuticals
Application
ANDA206251
Marketing category
ANDA
Marketing start
2020-04-07
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
5 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2022-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage70934-66270934-662-30IInactivated by FDA2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A206251-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2016-12-07
A206251-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2016-12-07
A206251-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2016-12-07
A206251-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2016-12-07
A206251-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2016-12-07
A206251-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2016-12-07

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-productTE code
A206251-001AB
A206251-002AB
A206251-003AB
A206251-004AB
A206251-005AB
A206251-006AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A206251-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-12-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-12-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-12-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-12-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A206251-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-12-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-12-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-12-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-12-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-12-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-12-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-005ARIPIPRAZOLE20MGTABLET / ORALAB2016-12-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-006ARIPIPRAZOLE30MGTABLET / ORALAB2016-12-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-001ARIPIPRAZOLE2MGTABLET / ORALAB2016-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-002ARIPIPRAZOLE5MGTABLET / ORALAB2016-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-003ARIPIPRAZOLE10MGTABLET / ORALAB2016-12-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-004ARIPIPRAZOLE15MGTABLET / ORALAB2016-12-072680178bc6a6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A206251-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206251-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206251-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206251-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206251-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206251-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206251-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206251-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A206251-004AB12680178bc6a6…

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70934-662-30ARIPIPRAZOLE30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70934-662ARIPIPRAZOLE TABLET [DENTON PHARMA, INC. DBA NORTHWIND PHARMACEUTICALS]1Legacy NDC, 1 package rows20210814_aa6ad389-08ab-577f-e053-2a95a90a02ec.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ARIPIPRAZOLEARIPIPRAZOLEAccord Healthcare, Inc.85cc7d25-414b-4b6f-a03a-48af908a16a12025-10-06Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206251
application number: ANDA206251
ARIPIPRAZOLEARIPIPRAZOLEA-S Medication Solutionsaaf7dc7e-04f3-442b-86d7-5f54d17d102c2022-09-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206251
application number: ANDA206251

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
402131ARIPiprazole 5 MG Oral TabletPSNaa6ad389-08ab-577f-e053-2a95a90a02ec1
402131aripiprazole 5 MG Oral TabletSCDaa6ad389-08ab-577f-e053-2a95a90a02ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-662-307093406623030 TABLET in 1 BOTTLE, PLASTIC (70934-662-30) 30 tablet2020-04-070000-00-00NoNoCurrent