Aripiprazole

Product NDC: 53808-1101
Requested package NDC: 53808-1101-1
11-digit product format: 538081101
Labeler code: 53808
Product ID: 53808-1101_e0aaca87-5e03-4971-a2c4-33d2e5dcfe28
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: DOH CENTRAL PHARMACY
Application: ANDA204838
Marketing category: ANDA
Marketing start: 2017-08-17
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	53808-1101	53808-1101-1	I	Inactivated by FDA		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 · 15 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…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
A204838-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17
A204838-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17
A204838-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17
A204838-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17
A204838-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17
A204838-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204838-001	AB
A204838-002	AB
A204838-003	AB
A204838-004	AB
A204838-005	AB
A204838-006	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	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-06-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-06-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-06-17	`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	A204838-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A204838-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204838-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204838-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A204838-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204838-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204838-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204838-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204838-004	AB	1	`2680178bc6a6…`

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
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53808-1101-1	2024-01-30	C162847	48780-1	1030e365-2107-111a-e063-dadaa90a10e2	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 Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53808-1101-1	Aripiprazole	30 in 1 BLISTER PACK	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53808-1101	ARIPIPRAZOLE TABLET [DOH CENTRAL PHARMACY]	1	Legacy NDC, 1 package rows	20190116_87dabf62-3148-4cb9-805d-e60aae395bbf.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	a1191a90-eb83-4a59-948c-b9774d2c83a5	2026-07-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838
Aripiprazole	ARIPIPRAZOLE	Major Pharmaceuticals	573c6bb6-941f-4413-8c23-826025385864	2026-05-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838
Aripiprazole	ARIPIPRAZOLE	Amneal Pharmaceuticals LLC	06dda03f-8481-46d6-af02-4f51e1a3a065	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	96172aa4-9e13-4eca-83d5-85a88c1782d3	2024-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838
Aripiprazole	ARIPIPRAZOLE	Proficient Rx LP	dbdc8fbe-c75f-4f17-a2cd-9f23802dcc5d	2019-11-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204838 application number: ANDA204838

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	87dabf62-3148-4cb9-805d-e60aae395bbf	1
402131	aripiprazole 5 MG Oral Tablet	SCD	87dabf62-3148-4cb9-805d-e60aae395bbf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53808-1101-1	53808110101	30 TABLET in 1 BLISTER PACK (53808-1101-1)	30 tablet	2017-08-17	0000-00-00	No	No	Current