Aripiprazole

Product NDC: 0904-7368
11-digit product format: 009047368
Labeler code: 0904
Product ID: 0904-7368_face01d9-5df3-4581-a4e7-e692444768a5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA204838
Marketing category: ANDA
Marketing start: 2016-06-20
Substance: ARIPIPRAZOLE
Active strength: 10 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A204838-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17
A204838-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17
A204838-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17
A204838-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17
A204838-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17
A204838-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204838-001	AB
A204838-002	AB
A204838-003	AB
A204838-004	AB
A204838-005	AB
A204838-006	AB

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`2680178bc6a6…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A204838-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204838-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aripiprazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE	10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82VFR53I78	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
573c6bb6-941f-4413-8c23-826025385864	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
915afeb5-0b22-42c0-86ea-77abf1c5fe15	Product name	1	20250307
51c1e9bf-32c5-4a7b-b010-f93a90af7b6e	Product name	1	20231010
351abe41-466c-4dd8-840a-0fdb68318bd5	Product name	1	20230316
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
34645f32-2ac4-41bf-9c61-8107e4764a26	Product name	1	20181210
f8ff9e17-cd6c-4547-98c3-f5db0d1fc25d	Product name	1	20180110
14eaf619-f285-4cd0-9f39-d9dd8f3d9c02	Product name	1	20170824
8223ef47-de85-24dd-a9c7-5a041d2634a2	Product name	9	20170223

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
0904-7368-06	Aripiprazole	50 in 1 CARTON	TABLET	50	4
0904-7368-06	Aripiprazole	1 in 1 BLISTER PACK	TABLET	1	4
0904-7368-61	Aripiprazole	100 in 1 CARTON	TABLET	100	4
0904-7368-61	Aripiprazole	1 in 1 BLISTER PACK	TABLET	1	4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-7368-06	EA - Each	0904-7368	3e8e187e-14df-485a-a6cf-75105a90139a	1	2024-04-05
0904-7368-61	EA - Each	0904-7368	42ebc737-617d-459a-a4eb-273ddb084e6c	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-7368	ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]	3	Current NDC, 4 package rows	20250330_573c6bb6-941f-4413-8c23-826025385864.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	a1191a90-eb83-4a59-948c-b9774d2c83a5	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838
Aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	573c6bb6-941f-4413-8c23-826025385864	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838 ndc (product): 0904-7368
Aripiprazole	ARIPIPRAZOLE	Amneal Pharmaceuticals LLC	06dda03f-8481-46d6-af02-4f51e1a3a065	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	96172aa4-9e13-4eca-83d5-85a88c1782d3	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
82VFR53I78	ARIPIPRAZOLE	129722-12-9	ARIPIPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
349545	ARIPiprazole 10 MG Oral Tablet	PSN	573c6bb6-941f-4413-8c23-826025385864	4
349490	ARIPiprazole 15 MG Oral Tablet	PSN	573c6bb6-941f-4413-8c23-826025385864	4
602964	ARIPiprazole 2 MG Oral Tablet	PSN	573c6bb6-941f-4413-8c23-826025385864	4
349553	ARIPiprazole 20 MG Oral Tablet	PSN	573c6bb6-941f-4413-8c23-826025385864	4
349547	ARIPiprazole 30 MG Oral Tablet	PSN	573c6bb6-941f-4413-8c23-826025385864	4
402131	ARIPiprazole 5 MG Oral Tablet	PSN	573c6bb6-941f-4413-8c23-826025385864	4
349545	aripiprazole 10 MG Oral Tablet	SCD	573c6bb6-941f-4413-8c23-826025385864	4
349490	aripiprazole 15 MG Oral Tablet	SCD	573c6bb6-941f-4413-8c23-826025385864	4
602964	aripiprazole 2 MG Oral Tablet	SCD	573c6bb6-941f-4413-8c23-826025385864	4
349553	aripiprazole 20 MG Oral Tablet	SCD	573c6bb6-941f-4413-8c23-826025385864	4
349547	aripiprazole 30 MG Oral Tablet	SCD	573c6bb6-941f-4413-8c23-826025385864	4
402131	aripiprazole 5 MG Oral Tablet	SCD	573c6bb6-941f-4413-8c23-826025385864	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0904-7368-06	00904736806	50 BLISTER PACK in 1 CARTON (0904-7368-06) / 1 TABLET in 1 BLISTER PACK	50 blister pack	2023-10-01	No	No	Current
0904-7368-61	00904736861	100 BLISTER PACK in 1 CARTON (0904-7368-61) / 1 TABLET in 1 BLISTER PACK	100 blister pack	2023-10-01	No	No	Current