ARIPIPRAZOLE

Product NDC: 70518-2827
11-digit product format: 705182827
Labeler code: 70518
Product ID: 70518-2827_d76dc4f3-dc36-154d-e053-2995a90a5e70
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA205363
Marketing category: ANDA
Marketing start: 2020-08-07
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 30 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	70518-2827		D	Discontinued by firm		2026-10-15
excluded package	package	70518-2827	70518-2827-0	D	Discontinued by firm		2026-10-15

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 · 24 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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`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	70518-2827-0	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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
A205363-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04
A205363-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04
A205363-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04
A205363-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04
A205363-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04
A205363-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205363-001	AB
A205363-002	AB
A205363-003	AB
A205363-004	AB
A205363-005	AB
A205363-006	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 · 264 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
2026-10-15 13:18:30	2026-09	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205363-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2017-12-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2017-12-04	`fd3edfee7708…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 7 · 264 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205363-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205363-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205363-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-004	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-005	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205363-006	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205363-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205363-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205363-003	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205363-004	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205363-005	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205363-006	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205363-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205363-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205363-003	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205363-004	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205363-005	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205363-006	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205363-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205363-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205363-003	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205363-004	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205363-005	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205363-006	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205363-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205363-002	AB	1	`79d66fd596c7…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70518-2827-0	2022-02-07	C162847	48780-1	d6a99b39-fe01-a426-e053-dadaa90af4c2	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
70518-2827-0	2022-01-28	C162847	48780-1	d6a99b39-fe01-a426-e053-dadaa90af4c2	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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ARIPIPRAZOLE	ARIPIPRAZOLE	A-S Medication Solutions	db6fc74e-4989-464d-9c19-a5b7a541fd46	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205363 application number: ANDA205363

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
70518-2827-0	70518282700	30 POUCH in 1 BOX (70518-2827-0) > 1 TABLET in 1 POUCH (70518-2827-1)	30 pouch	2020-08-07	0000-00-00	No	No	Current