aripiprazole

Product NDC: 0904-6656
11-digit product format: 009046656
Labeler code: 0904
Product ID: 0904-6656_b91e66d9-c64e-4503-835f-08d3916f9e1d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Major Pharmaceuticals
Application: ANDA201519
Marketing category: ANDA
Marketing start: 2015-04-28
Substance: ARIPIPRAZOLE
Active strength: 5 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
A201519-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28
A201519-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28
A201519-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28
A201519-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28
A201519-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28
A201519-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A201519-001	AB
A201519-002	AB
A201519-003	AB
A201519-004	AB
A201519-005	AB
A201519-006	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	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`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	A201519-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A201519-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A201519-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A201519-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A201519-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A201519-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A201519-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A201519-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A201519-004	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	5 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
402131	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
969c17aa-6abc-413c-8561-f1ad8fdde3e5	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	Strength	SPL version
0904-6656-40	aripiprazole	500 in 1 BOTTLE	TABLET	500		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0904-6656-40	EA - Each	0904-6656	420e3f7c-f1c8-4642-9594-7f6ade87e429	1	2017-07-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0904-6656	ARIPIPRAZOLE TABLET [MAJOR PHARMACEUTICALS]	6	Current NDC, Legacy NDC, 1 package rows	20250116_969c17aa-6abc-413c-8561-f1ad8fdde3e5.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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1ad7d167-1235-4c5c-8159-da8972240ede	2026-07-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	9b695d4b-3794-4b89-8575-6feb83697ccc	2026-05-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	969c17aa-6abc-413c-8561-f1ad8fdde3e5	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519 ndc (product): 0904-6656
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	2c2b0172-b186-4be4-a002-4a26adf120c6	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	a3c0be94-c6c0-47e2-892f-c51f100fb3a3	2025-08-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	ST. MARY'S MEDICAL PARK PHARMACY	35a86989-862e-b0bb-e063-6394a90a7ec1	2025-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Torrent Pharmaceuticals Limited	3988e66f-339c-451e-9f8a-9d0c0a2a381b	2025-03-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f81d9b82-5879-3c0a-e053-6294a90ac23e	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	faa3032b-d9a1-45dd-88be-abb432223f13	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	e7b6a156-8001-441c-bfd3-bf8987a339e8	2024-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	b62837db-1949-4dba-9e2f-714a9f136f5a	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	d130836c-5f1c-4779-ac6c-6350752dc015	2024-10-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519
aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	ab3973f3-3db8-4db2-8258-1b21af7b6380	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 201519 application number: ANDA201519

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
402131	ARIPiprazole 5 MG Oral Tablet	PSN	969c17aa-6abc-413c-8561-f1ad8fdde3e5	9
402131	aripiprazole 5 MG Oral Tablet	SCD	969c17aa-6abc-413c-8561-f1ad8fdde3e5	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0904-6656-40	00904665640	500 TABLET in 1 BOTTLE (0904-6656-40)	500 tablet	2015-04-28	0000-00-00	No	No	Current