FDA.reportPublic FDA data

Aripiprazole

Product NDC
50268-087
11-digit product format
502680087
Labeler code
50268
Product ID
50268-087_3d49db38-3629-6bb9-e063-6294a90a4b4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Aripiprazole
Dosage form
TABLET
Route
ORAL
Labeler
AvPAK
Application
ANDA205064
Marketing category
ANDA
Marketing start
2016-04-28
Substance
ARIPIPRAZOLE
Active strength
2 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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A205064-001ARIPIPRAZOLE2MGTABLET / ORALAB2015-04-28a50c72e98297…
2026-08-01 22:54:322026-06A205064-002ARIPIPRAZOLE5MGTABLET / ORALAB2015-04-28a50c72e98297…
2026-08-01 22:54:322026-06A205064-003ARIPIPRAZOLE10MGTABLET / ORALAB2015-04-28a50c72e98297…
2026-08-01 22:54:322026-06A205064-004ARIPIPRAZOLE15MGTABLET / ORALAB2015-04-28a50c72e98297…
2026-08-01 22:54:322026-06A205064-005ARIPIPRAZOLE20MGTABLET / ORALAB2015-04-28a50c72e98297…
2026-08-01 22:54:322026-06A205064-006ARIPIPRAZOLE30MGTABLET / ORALAB2015-04-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A205064-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A205064-002AB1a50c72e98297…
2026-08-01 22:54:322026-06A205064-003AB1a50c72e98297…
2026-08-01 22:54:322026-06A205064-004AB1a50c72e98297…
2026-08-01 22:54:322026-06A205064-005AB1a50c72e98297…
2026-08-01 22:54:322026-06A205064-006AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
ndc (product): 50268-087
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARIPIPRAZOLE2 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
7df4c83e-13d8-25b1-57eb-08d26ba03565Available 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
50268-087-11Aripiprazole1 in 1 BLISTER PACKTABLET16
50268-087-12Aripiprazole20 in 1 BOX, UNIT-DOSETABLET206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-087ARIPIPRAZOLE (ARIPIPRAZOLE) TABLET [AVPAK]5Current NDC, Legacy NDC, 2 package rows20240110_7df4c83e-13d8-25b1-57eb-08d26ba03565.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349545ARIPiprazole 10 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349490ARIPiprazole 15 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
602964ARIPiprazole 2 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349553ARIPiprazole 20 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349547ARIPiprazole 30 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
402131ARIPiprazole 5 MG Oral TabletPSN7df4c83e-13d8-25b1-57eb-08d26ba035656
349545aripiprazole 10 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349490aripiprazole 15 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
602964aripiprazole 2 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349553aripiprazole 20 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
349547aripiprazole 30 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656
402131aripiprazole 5 MG Oral TabletSCD7df4c83e-13d8-25b1-57eb-08d26ba035656

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-087-11502680087111 in 1 BLISTER PACKHistorical
50268-087-125026800871220 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-087-12) / 1 TABLET in 1 BLISTER PACK (50268-087-11) 20 blister pack2016-04-280000-00-00NoNoCurrent