Aripiprazole

Product NDC: 68788-7749
11-digit product format: 687887749
Labeler code: 68788
Product ID: 68788-7749_66441958-c5c0-48a4-850d-bfee07ecff4b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Preferred Pharmaceuticals, Inc.
Application: ANDA206174
Marketing category: ANDA
Marketing start: 2020-07-01
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
A206174-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12
A206174-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12
A206174-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12
A206174-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12
A206174-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12
A206174-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206174-001	AB
A206174-002	AB
A206174-003	AB
A206174-004	AB
A206174-005	AB
A206174-006	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	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-12	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-12	`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	A206174-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206174-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206174-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206174-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206174-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206174-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206174-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206174-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206174-004	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
36fb0c13-dfae-46ac-bb71-0b53fe5649f4	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
68788-7749-1	Aripiprazole	100 in 1 BOTTLE	TABLET	100	7
68788-7749-2	Aripiprazole	20 in 1 BOTTLE	TABLET	20	7
68788-7749-3	Aripiprazole	30 in 1 BOTTLE	TABLET	30	7
68788-7749-6	Aripiprazole	60 in 1 BOTTLE	TABLET	60	7
68788-7749-9	Aripiprazole	90 in 1 BOTTLE	TABLET	90	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68788-7749	ARIPIPRAZOLE TABLET [PREFERRED PHARMACEUTICALS, INC.]	6	Current NDC, Legacy NDC, 5 package rows	20250205_36fb0c13-dfae-46ac-bb71-0b53fe5649f4.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	69af5199-f872-4298-8d09-035e2127d3d4	2026-06-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Unit Dose Solutions, Inc.	535f4fbd-b6a7-7611-e063-6294a90a5c43	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	c092a736-16e2-4dd0-8769-cb766a62f4d9	2026-05-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals, Inc.	36fb0c13-dfae-46ac-bb71-0b53fe5649f4	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174 ndc (product): 68788-7749
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	2bc00231-c2e7-4b9d-93a1-fb796fd8d591	2026-02-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	47430dfa-9377-6c31-e063-6394a90a86a9	2025-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Quallent Pharmaceuticals Health LLC	0e0d42ad-f4c6-4e30-adc2-ab1d122428ec	2025-12-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Ajanta Pharma USA Inc.	d0f910b5-adef-4a93-9369-70f1ed541503	2025-10-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	13339e7f-a8b4-430d-b623-47372de98348	2024-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	fd2fa4da-2ee9-4965-b1f8-ce1c8b73ba93	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206174 application number: ANDA206174

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	36fb0c13-dfae-46ac-bb71-0b53fe5649f4	7
402131	aripiprazole 5 MG Oral Tablet	SCD	36fb0c13-dfae-46ac-bb71-0b53fe5649f4	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68788-7749-1	68788774901	100 TABLET in 1 BOTTLE (68788-7749-1)	100 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7749-2	68788774902	20 TABLET in 1 BOTTLE (68788-7749-2)	20 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7749-3	68788774903	30 TABLET in 1 BOTTLE (68788-7749-3)	30 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7749-6	68788774906	60 TABLET in 1 BOTTLE (68788-7749-6)	60 tablet	2020-07-01	0000-00-00	No	No	Current
68788-7749-9	68788774909	90 TABLET in 1 BOTTLE (68788-7749-9)	90 tablet	2020-07-01	0000-00-00	No	No	Current