Aripiprazole

Product NDC: 17856-0570
11-digit product format: 178560570
Labeler code: 17856
Product ID: 17856-0570_18e75452-52a2-4304-83a0-9d3360991084
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: SOLUTION
Route: ORAL
Labeler: ATLANTIC BIOLOGICALS CORP.
Application: ANDA204171
Marketing category: ANDA
Marketing start: 2015-08-17
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 1 mg/mL
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2022-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	17856-0570		I	Inactivated by FDA	2026-08-07
excluded package	package	17856-0570	17856-0570-1	I	Inactivated by FDA	2026-08-07
excluded package	package	17856-0570	17856-0570-2	I	Inactivated by FDA	2026-08-07

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 · 6 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
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	17856-0570-2	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	17856-0570-1	`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	17856-0570-2	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	17856-0570-1	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204171-001	ARIPIPRAZOLE	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA		2015-08-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204171-001	AA

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 2 · 41 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	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204171-001	ARIPIPRAZOLE	1MG/ML	SOLUTION / ORAL	AA	2015-08-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	A204171-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204171-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204171-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204171-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204171-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204171-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204171-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204171-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204171-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204171-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204171-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204171-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204171-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204171-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204171-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204171-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204171-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204171-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204171-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204171-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204171-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204171-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204171-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204171-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204171-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204171-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204171-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204171-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204171-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204171-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204171-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204171-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204171-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204171-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204171-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204171-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204171-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204171-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204171-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204171-001	AA	1	`cb3db0bc1861…`

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, Related label table
NDC	Effective	Related label
17856-0570-1	2024-05-16	These highlights do not include all the information needed to use use ARIPIPRAZOLE ORAL SOLUTION safely and effectively. See full prescribing information for ARIPIPRAZOLE ORAL SOLUTION. ARIPIPRAZOLE oral solution Initial U.S. Approval: 2002
17856-0570-2	2024-05-16	These highlights do not include all the information needed to use use ARIPIPRAZOLE ORAL SOLUTION safely and effectively. See full prescribing information for ARIPIPRAZOLE ORAL SOLUTION. ARIPIPRAZOLE oral solution Initial U.S. Approval: 2002
17856-0570-1	2023-01-30	These highlights do not include all the information needed to use use ARIPIPRAZOLE ORAL SOLUTION safely and effectively. See full prescribing information for ARIPIPRAZOLE ORAL SOLUTION. ARIPIPRAZOLE oral solution Initial U.S. Approval: 2002
17856-0570-2	2023-01-30	These highlights do not include all the information needed to use use ARIPIPRAZOLE ORAL SOLUTION safely and effectively. See full prescribing information for ARIPIPRAZOLE ORAL SOLUTION. ARIPIPRAZOLE oral solution Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17856-0570-1	Aripiprazole	5 mL in 1 CUP, UNIT-DOSE	SOLUTION	5	3
17856-0570-1	Aripiprazole	72 in 1 BOX, UNIT-DOSE	SOLUTION	72	3
17856-0570-2	Aripiprazole	48 in 1 BOX, UNIT-DOSE	SOLUTION	48	3
17856-0570-2	Aripiprazole	5 mL in 1 SYRINGE	SOLUTION	5	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17856-0570	ARIPIPRAZOLE SOLUTION [ATLANTIC BIOLOGICALS CORP.]	3	Legacy NDC, 4 package rows	20240517_dc7ca387-4f62-404c-86b6-d18cdb574086.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Lannett Company, Inc.	e7292c4c-e332-4ed4-9086-f130d223b6ae	2025-01-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204171 application number: ANDA204171

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
485496	ARIPiprazole 1 MG in 1 mL Oral Solution	PSN	dc7ca387-4f62-404c-86b6-d18cdb574086	3
485496	aripiprazole 1 MG/ML Oral Solution	SCD	dc7ca387-4f62-404c-86b6-d18cdb574086	3
485496	aripiprazole 1 MG per 1 ML Oral Solution	SY	dc7ca387-4f62-404c-86b6-d18cdb574086	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17856-0570-1	17856057001	72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0570-1) > 5 mL in 1 CUP, UNIT-DOSE		2020-06-11	0000-00-00	No	No	Current
17856-0570-2	17856057002	48 SYRINGE in 1 BOX, UNIT-DOSE (17856-0570-2) > 5 mL in 1 SYRINGE	48 syringe	2021-03-15	0000-00-00	No	No	Current