Aripiprazole

Product NDC: 68071-2708
11-digit product format: 680712708
Labeler code: 68071
Product ID: 68071-2708_df5fc3e2-401a-415d-e053-2995a90ae69c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA207105
Marketing category: ANDA
Marketing start: 2019-02-27
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 10 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	68071-2708		I	Inactivated by FDA		2026-10-05
excluded package	package	68071-2708	68071-2708-3	I	Inactivated by FDA		2026-10-05

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68071-2708-3	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	68071-2708-3	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	68071-2708-3	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	68071-2708-3	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	68071-2708-3	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	68071-2708-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68071-2708-3	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68071-2708-3	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68071-2708-3	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A207105-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21
A207105-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21
A207105-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21
A207105-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21
A207105-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21
A207105-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A207105-001	AB
A207105-002	AB
A207105-003	AB
A207105-004	AB
A207105-005	AB
A207105-006	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 · 258 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
2026-09-14 22:38:34	2026-08	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A207105-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-003	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-004	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-005	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A207105-006	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A207105-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-003	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-004	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-005	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A207105-006	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A207105-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207105-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207105-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207105-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207105-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207105-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207105-004	AB	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

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

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
68071-2708-3	2025-01-30	C162847	48780-1	2cef2736-b589-d83d-e063-dadaa90ab31f	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
68071-2708-3	Aripiprazole	30 in 1 BOTTLE	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-2708	ARIPIPRAZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]	1	Legacy NDC, 1 package rows	20220520_df5fbfc7-5d12-28d4-e053-2995a90a86e5.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 2 · 26 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	1d593ada-256d-4dec-9a26-2a6a67d97205	2026-07-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	bc3fde41-2f24-44e2-815d-15fe55bd68b3	2026-07-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	506fa28f-6f98-4632-bce8-72a9cb507c90	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	f713c38e-cc49-4243-96b9-32d5dbbcf9cb	2026-07-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f3a705-9412-0f88-e063-6294a90a2b53	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	55f446b0-caa2-aca8-e063-6294a90af441	2026-07-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	52bbfc8f-fa17-839e-e063-6394a90a6316	2026-05-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Coupler LLC	50214c47-2ea3-b373-e063-6394a90aad23	2026-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	6f580e75-61ab-4c7b-bb3f-f027a9603f84	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	REMEDYREPACK INC.	433cdc7d-465a-4ad4-bd84-cabd37e15f51	2026-03-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	ff8dc838-ca1a-49d3-8938-5ae645574a75	2026-03-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1e8d889e-126b-4627-a2cc-34f2d35a5d67	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	1ef9e44f-5672-47c2-97e9-286e1b84417d	2026-01-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	4bda6f17-d87c-4009-b329-99275c56106f	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Bryant Ranch Prepack	fb40b669-4e37-4087-8fb1-3ac140543602	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	A-S Medication Solutions	554db933-aa80-4685-bcd5-58c84571c19c	2026-01-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Ascend Laboratories, LLC	c7040fef-96a7-4429-9a8e-ec3ab17a8019	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	facdb9a9-612f-e59a-e053-6394a90a1fa7	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Direct_Rx	fcea91c3-e428-8991-e053-6394a90a099d	2025-01-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals Inc.	34127431-6ad7-402f-bc22-1429c55d921c	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105

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
349545	ARIPiprazole 10 MG Oral Tablet	PSN	df5fbfc7-5d12-28d4-e053-2995a90a86e5	1
349545	aripiprazole 10 MG Oral Tablet	SCD	df5fbfc7-5d12-28d4-e053-2995a90a86e5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-2708-3	68071270803	30 TABLET in 1 BOTTLE (68071-2708-3)	30 tablet	2022-05-19	0000-00-00	No	No	Current