Aripiprazole

Product NDC: 76483-100
11-digit product format: 764830100
Labeler code: 76483
Product ID: 76483-100_d7622fbb-a43c-46db-bde4-d05ed7bff185
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET, ORALLY DISINTEGRATING
Route: ORAL
Labeler: SQUARE PHARMACEUTICALS LIMITED
Application: ANDA090165
Marketing category: ANDA
Marketing start: 2022-07-20
Substance: ARIPIPRAZOLE
Active strength: 10 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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A090165-001	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28
A090165-002	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28
A090165-003	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28
A090165-004	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A090165-001	AB
A090165-002	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 5 · 164 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	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090165-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-003	ARIPIPRAZOLE	20MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-004	ARIPIPRAZOLE	30MG	TABLET, ORALLY DISINTEGRATING / ORAL		2018-08-28	`d06236e962d9…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A090165-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090165-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090165-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090165-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090165-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090165-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090165-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090165-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090165-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090165-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090165-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090165-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090165-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090165-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090165-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090165-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090165-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090165-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090165-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090165-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090165-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090165-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090165-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090165-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090165-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090165-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090165-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090165-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090165-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090165-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090165-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090165-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090165-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
643019	Internal RxNorm lookup
643022	Internal RxNorm lookup
643027	Internal RxNorm lookup
643058	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
0f9b1fd8-a648-45c9-8655-14de07439f34	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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76483-100-00	Aripiprazole	30 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	30	3
76483-100-01	Aripiprazole	60 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	60	3
76483-100-02	Aripiprazole	90 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	90	3
76483-100-03	Aripiprazole	120 in 1 BOTTLE	TABLET, ORALLY DISINTEGRATING	120	3
76483-100-04	Aripiprazole	30 in 1 CARTON	TABLET, ORALLY DISINTEGRATING	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76483-100	ARIPIPRAZOLE TABLET, ORALLY DISINTEGRATING [SQUARE PHARMACEUTICALS LIMITED]	3	Current NDC, Legacy NDC, 5 package rows	20230706_0f9b1fd8-a648-45c9-8655-14de07439f34.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Viona Pharmaceuticals Inc.	73c5e380-b7b1-4362-a827-71881574ff48	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090165 application number: ANDA090165
Aripiprazole	ARIPIPRAZOLE	SQUARE PHARMACEUTICALS LIMITED	0f9b1fd8-a648-45c9-8655-14de07439f34	2023-07-02		Exact identifier application applno (ANDA): 090165 application number: ANDA090165 ndc (product): 76483-100

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
643019	ARIPiprazole 10 MG Disintegrating Oral Tablet	PSN	0f9b1fd8-a648-45c9-8655-14de07439f34	3
643022	ARIPiprazole 15 MG Disintegrating Oral Tablet	PSN	0f9b1fd8-a648-45c9-8655-14de07439f34	3
643027	ARIPiprazole 20 MG Disintegrating Oral Tablet	PSN	0f9b1fd8-a648-45c9-8655-14de07439f34	3
643058	ARIPiprazole 30 MG Disintegrating Oral Tablet	PSN	0f9b1fd8-a648-45c9-8655-14de07439f34	3
643019	aripiprazole 10 MG Disintegrating Oral Tablet	SCD	0f9b1fd8-a648-45c9-8655-14de07439f34	3
643022	aripiprazole 15 MG Disintegrating Oral Tablet	SCD	0f9b1fd8-a648-45c9-8655-14de07439f34	3
643027	aripiprazole 20 MG Disintegrating Oral Tablet	SCD	0f9b1fd8-a648-45c9-8655-14de07439f34	3
643058	aripiprazole 30 MG Disintegrating Oral Tablet	SCD	0f9b1fd8-a648-45c9-8655-14de07439f34	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76483-100-00	76483010000	30 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-00)	2022-07-20	0000-00-00	No	No	Current
76483-100-01	76483010001	60 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-01)	2022-07-20	0000-00-00	No	No	Current
76483-100-02	76483010002	90 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-02)	2022-07-20	0000-00-00	No	No	Current
76483-100-03	76483010003	120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76483-100-03)	2022-07-20	0000-00-00	No	No	Current
76483-100-04	76483010004	30 TABLET, ORALLY DISINTEGRATING in 1 CARTON (76483-100-04)	2023-02-22		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ARIPIPRAZOLE ORALLY DISINTEGRATING TABLETS	SQUARE PHARMACEUTICALS LIMITED \| SQUARE PHARMACEUTICALS LIMITED, Dhaka unit	2023-07-02	HUMAN PRESCRIPTION DRUG LABEL	3