Aripiprazole

Product NDC: 17856-0680
11-digit product format: 178560680
Labeler code: 17856
Product ID: 17856-0680_1fbc5098-a838-41c5-bcff-9771f2ff3e74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Atlantic Biologicals Corps
Application: ANDA202101
Marketing category: ANDA
Marketing start: 2015-04-28
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	17856-0680		I	Inactivated by FDA		2026-08-03
excluded package	package	17856-0680	17856-0680-1	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 · 38 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	17856-0680-1	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	17856-0680-1	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	17856-0680-1	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	17856-0680-1	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	17856-0680-1	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	17856-0680-1	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	17856-0680-1	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	17856-0680-1	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	17856-0680-1	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	17856-0680-1	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	17856-0680-1	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	17856-0680-1	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	17856-0680-1	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0680-1	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0680-1	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	17856-0680-1	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	17856-0680-1	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	17856-0680-1	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	17856-0680-1	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A202101-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28
A202101-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28
A202101-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28
A202101-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28
A202101-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28
A202101-006	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
A202101-001	AB
A202101-002	AB
A202101-003	AB
A202101-004	AB
A202101-005	AB
A202101-006	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	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2015-04-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2015-04-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-004	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	A202101-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202101-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202101-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202101-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202101-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202101-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202101-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202101-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202101-004	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
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
17856-0680-1	2021-01-29	C162847	48780-1	ba0f9c33-5255-a910-e053-dadaa90a0b85	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
17856-0680-1	Aripiprazole	100 in 1 BOTTLE	TABLET	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0680	ARIPIPRAZOLE TABLET [ATLANTIC BIOLOGICALS CORPS]	3	Legacy NDC, 1 package rows	20191031_9fc9cdf0-5a9f-445a-a7f6-b43c16e7eb08.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	119e3387-39a2-4fe5-904b-c2d008425c0a	2026-07-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	99747897-22fe-4bee-9942-6349c0c8f6b0	2026-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	56439ef6-a07e-34c9-e063-6294a90a77c3	2026-07-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52cc86ba-2c4f-1aba-e063-6294a90a844e	2026-05-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	512874e6-6d00-2623-e063-6394a90aa4bc	2026-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	02a4af27-c83c-4166-950c-7a1cb12d198d	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Inc.	a10a5427-58b1-42dd-964c-3f8c78770534	2025-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101
Aripiprazole	ARIPIPRAZOLE	Alembic Pharmaceuticals Limited	793fc904-2f11-4f97-a0ac-4d6910cac0f9	2023-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202101 application number: ANDA202101

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	9fc9cdf0-5a9f-445a-a7f6-b43c16e7eb08	3
402131	aripiprazole 5 MG Oral Tablet	SCD	9fc9cdf0-5a9f-445a-a7f6-b43c16e7eb08	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
17856-0680-1	17856068001	100 in 1 BOTTLE	Historical