ARIPIPRAZOLE

Product NDC
31722-923
11-digit product format
317220923
Labeler code
31722
Product ID
31722-923_c99f3445-aceb-47c7-9f35-4f906aad08aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA205064
Marketing category
ANDA
Marketing start
2017-08-01
Substance
ARIPIPRAZOLE
Active strength
20 mg/1
Pharmacologic classes
Atypical Antipsychotic [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A205064-001ARIPIPRAZOLEARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28
A205064-002ARIPIPRAZOLEARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28
A205064-003ARIPIPRAZOLEARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28
A205064-004ARIPIPRAZOLEARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28
A205064-005ARIPIPRAZOLEARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28
A205064-006ARIPIPRAZOLEARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A205064-001AB
A205064-002AB
A205064-003AB
A205064-004AB
A205064-005AB
A205064-006AB

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 UTC2026-02A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-282680178bc6a6…

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 UTC2026-02A205064-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-004AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-005AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A205064-006AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-004AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-005AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A205064-006AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A205064-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-004AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-005AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A205064-006AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-004AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-005AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A205064-006AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-004AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-005AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A205064-006AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-004AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-005AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A205064-006AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A205064-004AB12680178bc6a6…

Additional Listing Data#

Finished product
Yes
Brand name base
ARIPIPRAZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
82VFR53I78Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
349490Internal RxNorm lookup
349545Internal RxNorm lookup
349547Internal RxNorm lookup
349553Internal RxNorm lookup
402131Internal RxNorm lookup
602964Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3718e585-06b9-40fd-a3eb-18b6497a4235Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
31722-923-01ARIPIPRAZOLE100 in 1 BOTTLETABLET1001
31722-923-30ARIPIPRAZOLE30 in 1 BOTTLETABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-923ARIPIPRAZOLE TABLET [CAMBER PHARMACEUTICALS, INC.]1Current NDC, 2 package rows20230321_3718e585-06b9-40fd-a3eb-18b6497a4235.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.414b7fd2-6a63-af39-e063-6394a90a00b82025-10-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEPD-Rx Pharmaceuticals, Inc.0cf6655e-d59a-4ebd-9698-195cad2adbd52025-10-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEAvPAK7df4c83e-13d8-25b1-57eb-08d26ba035652025-08-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals, Inc.3cf72cc6-ae43-bfd5-e063-6294a90a18b02025-08-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEAmerican Health Packaging80e079f0-faf5-4c0c-b1a8-9bc3cc2cde002025-08-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLENuCare Pharmaceuticals,Inc.3726d102-dd9f-645e-e063-6294a90aeb9e2025-06-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEDirect_Rxf823bc23-27f3-2397-e053-6294a90a365a2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEA-S Medication Solutions89c2cddc-2ae3-4505-adf9-018542c713bf2024-04-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack3c0109f6-0549-4f91-a259-d9d6d7329b912024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEBryant Ranch Prepack6b0c3767-d397-4c7f-b229-083620d9ae6b2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLECamber Pharmaceuticals, Inc.2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa2024-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLENorthStar RxLLCf87dbfe4-5417-47c9-a97f-d246cfc100232023-08-30Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.0a6fa113-6bb2-4f88-af07-ce0914c98ff22023-06-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEXLCare Pharmaceuticals, Inc.b284b294-40a0-4ccd-b7b7-b61267cd4e762023-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
AripiprazoleARIPIPRAZOLEExelan Pharmaceuticals, Inc.705190bf-9f9d-4183-a56b-4eeafeacde592018-12-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
ARIPIPRAZOLEARIPIPRAZOLECamber Pharmaceuticals, Inc.3718e585-06b9-40fd-a3eb-18b6497a42352017-08-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 205064
application number: ANDA205064
ndc (product): 31722-923

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN3718e585-06b9-40fd-a3eb-18b6497a42351
349490ARIPiprazole 15 MG Oral TabletPSN3718e585-06b9-40fd-a3eb-18b6497a42351
602964ARIPiprazole 2 MG Oral TabletPSN3718e585-06b9-40fd-a3eb-18b6497a42351
349553ARIPiprazole 20 MG Oral TabletPSN3718e585-06b9-40fd-a3eb-18b6497a42351
349547ARIPiprazole 30 MG Oral TabletPSN3718e585-06b9-40fd-a3eb-18b6497a42351
402131ARIPiprazole 5 MG Oral TabletPSN3718e585-06b9-40fd-a3eb-18b6497a42351
349545aripiprazole 10 MG Oral TabletSCD3718e585-06b9-40fd-a3eb-18b6497a42351
349490aripiprazole 15 MG Oral TabletSCD3718e585-06b9-40fd-a3eb-18b6497a42351
602964aripiprazole 2 MG Oral TabletSCD3718e585-06b9-40fd-a3eb-18b6497a42351
349553aripiprazole 20 MG Oral TabletSCD3718e585-06b9-40fd-a3eb-18b6497a42351
349547aripiprazole 30 MG Oral TabletSCD3718e585-06b9-40fd-a3eb-18b6497a42351
402131aripiprazole 5 MG Oral TabletSCD3718e585-06b9-40fd-a3eb-18b6497a42351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-923-0131722092301100 TABLET in 1 BOTTLE (31722-923-01) 100 tablet2017-08-01NoNoCurrent
31722-923-303172209233030 TABLET in 1 BOTTLE (31722-923-30) 30 tablet2017-08-01NoNoCurrent