Aripiprazole

Product NDC: 82804-023
Requested package NDC: 82804-023-30
11-digit product format: 828040023
Labeler code: 82804
Product ID: 82804-023_fbd81df7-8482-493e-bfc5-a3352f466b9e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA203908
Marketing category: ANDA
Marketing start: 2015-10-08
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 43.

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
A203908-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08
A203908-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08
A203908-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08
A203908-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08
A203908-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08
A203908-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A203908-001	AB
A203908-002	AB
A203908-003	AB
A203908-004	AB
A203908-005	AB
A203908-006	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 · 258 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
2026-09-14 22:38:34	2026-08	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A203908-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A203908-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A203908-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A203908-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A203908-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A203908-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A203908-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A203908-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A203908-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A203908-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349545	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
fbd81df7-8482-493e-bfc5-a3352f466b9e	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
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
82804-023-30	Aripiprazole	30 in 1 BOTTLE	TABLET	30	1
82804-023-60	Aripiprazole	60 in 1 BOTTLE	TABLET	60	1
82804-023-90	Aripiprazole	90 in 1 BOTTLE	TABLET	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-023	ARIPIPRAZOLE TABLET [PROFICIENT RX LP]	1	Current NDC, 3 package rows	20231012_fbd81df7-8482-493e-bfc5-a3352f466b9e.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	b72c0cff-9f4d-42e2-b884-d06dea3e6378	2026-09-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	Aurobindo Pharma Limited	7bf7d35e-46a1-4e8f-aeb5-8a93223a4abc	2026-07-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	a8edb057-18a3-446d-8af0-672c97933a88	2025-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	385301f5-e59d-42d5-8544-aadf0ee0c967	2025-04-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	c8a94428-b6d2-428b-a3a5-7b983d572fab	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	fbd81df7-8482-493e-bfc5-a3352f466b9e	2023-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908 ndc (package): 82804-023-30 ndc (product): 82804-023 ndc11 (package): 82804002330
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	19a3c2f2-11eb-4ec9-ac38-134168bdf99c	2022-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	11202c0a-7401-41c9-b1e7-d93739fcd36f	2022-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 203908 application number: ANDA203908

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	fbd81df7-8482-493e-bfc5-a3352f466b9e	1
349545	aripiprazole 10 MG Oral Tablet	SCD	fbd81df7-8482-493e-bfc5-a3352f466b9e	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-023-30	82804002330	30 TABLET in 1 BOTTLE (82804-023-30)	30 tablet	2023-10-11	No	No	Current