Aripiprazole

Product NDC: 63739-069
Requested package NDC: 63739-069-33
11-digit product format: 637390069
Labeler code: 63739
Product ID: 63739-069_f1d7e020-1723-6a0e-e053-2a95a90a0de2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA205064
Marketing category: ANDA
Marketing start: 2021-11-09
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2024-12-31
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	63739-069	63739-069-33	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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	63739-069	63739-069-33	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

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
A205064-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28
A205064-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28
A205064-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28
A205064-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28
A205064-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28
A205064-006	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
A205064-001	AB
A205064-002	AB
A205064-003	AB
A205064-004	AB
A205064-005	AB
A205064-006	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	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-004	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	A205064-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205064-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205064-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205064-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205064-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205064-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205064-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205064-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205064-004	AB	1	`2680178bc6a6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-069-33	EA - Each	63739-069	74a59a58-9bc8-42db-9e1e-9b0361dd0130	1	2022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-069	ARIPIPRAZOLE TABLET [MCKESSON CORPORATION DBA SKY PACKAGING]	5	Legacy NDC	20241222_d05fcc78-c7bc-386e-e053-2995a90a6dbd.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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	414b7fd2-6a63-af39-e063-6394a90a00b8	2025-10-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	PD-Rx Pharmaceuticals, Inc.	0cf6655e-d59a-4ebd-9698-195cad2adbd5	2025-10-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	AvPAK	7df4c83e-13d8-25b1-57eb-08d26ba03565	2025-08-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals, Inc.	3cf72cc6-ae43-bfd5-e063-6294a90a18b0	2025-08-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	American Health Packaging	80e079f0-faf5-4c0c-b1a8-9bc3cc2cde00	2025-08-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NuCare Pharmaceuticals,Inc.	3726d102-dd9f-645e-e063-6294a90aeb9e	2025-06-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	f823bc23-27f3-2397-e053-6294a90a365a	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	89c2cddc-2ae3-4505-adf9-018542c713bf	2024-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	3c0109f6-0549-4f91-a259-d9d6d7329b91	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	6b0c3767-d397-4c7f-b229-083620d9ae6b	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	2d8d574b-fbf4-4d2c-a37c-25556ecbf1aa	2024-02-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	NorthStar RxLLC	f87dbfe4-5417-47c9-a97f-d246cfc10023	2023-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	0a6fa113-6bb2-4f88-af07-ce0914c98ff2	2023-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	XLCare Pharmaceuticals, Inc.	b284b294-40a0-4ccd-b7b7-b61267cd4e76	2023-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
Aripiprazole	ARIPIPRAZOLE	Exelan Pharmaceuticals, Inc.	705190bf-9f9d-4183-a56b-4eeafeacde59	2018-12-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064
ARIPIPRAZOLE	ARIPIPRAZOLE	Camber Pharmaceuticals, Inc.	3718e585-06b9-40fd-a3eb-18b6497a4235	2017-08-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205064 application number: ANDA205064

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
63739-069-33	63739006933	3 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-069-33) > 10 TABLET in 1 BLISTER PACK	3 blister pack	2021-11-09	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	2024-12-20	HUMAN PRESCRIPTION DRUG LABEL	5