Aripiprazole

Product NDC: 63739-413
Requested package NDC: 63739-413-10
11-digit product format: 637390413
Labeler code: 63739
Product ID: 63739-413_b466e9af-1a1d-5026-e053-2995a90a92a3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA203908
Marketing category: ANDA
Marketing start: 2015-10-08
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	63739-413	63739-413-10	D	Discontinued by firm		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`

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
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 · 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	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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-10-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-10-08	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-10-08	`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	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…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A203908-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A203908-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A203908-004	AB	1	`2680178bc6a6…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-413-10	2020-07-22	C162847	48780-1	ab0e2407-2e8e-f274-e053-dbdaa90a6471	These highlights do not include all the information needed to use ARIPIPRAZOLE TABLETS safely and effectively. See full prescribing information for ARIPIPRAZOLE TABLETS. ARIPIPRAZOLE tablets, for oral use Initial U.S. Approval: 2002

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-413-10	EA - Each	63739-413	dd4948bd-4b4b-4301-93a3-4d884798edd5	1	2019-03-12

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-413-10	63739041310	100 TABLET in 1 BOTTLE (63739-413-10)	100 tablet	2019-01-21	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aripiprazole	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2024-01-03	HUMAN PRESCRIPTION DRUG LABEL	4