Aripiprazole

Product NDC: 43598-734
11-digit product format: 435980734
Labeler code: 43598
Product ID: 43598-734_427aabb6-82db-806e-e063-6394a90a0d33
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole orally disintegrating
Dosage form: TABLET
Route: ORAL
Labeler: Dr. Reddy's Laboratories Inc
Application: ANDA207240
Marketing category: ANDA
Marketing start: 2018-05-15
Substance: ARIPIPRAZOLE
Active strength: 15 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A207240-001	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-18
A207240-002	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB		2018-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A207240-001	AB
A207240-002	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 3 · 82 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	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207240-001	ARIPIPRAZOLE	10MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207240-002	ARIPIPRAZOLE	15MG	TABLET, ORALLY DISINTEGRATING / ORAL	AB	2018-04-18	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A207240-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A207240-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207240-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A207240-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A207240-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A207240-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207240-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A207240-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207240-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A207240-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207240-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A207240-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207240-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A207240-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207240-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A207240-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207240-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A207240-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A207240-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A207240-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207240-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A207240-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207240-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A207240-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207240-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A207240-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A207240-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A207240-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207240-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A207240-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A207240-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A207240-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A207240-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A207240-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A207240-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A207240-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A207240-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A207240-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A207240-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A207240-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aripiprazole
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
82VFR53I78	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
643019	Internal RxNorm lookup
643022	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
394ea4a4-3991-4f98-b38f-56e9335d66b3	Available on FDA.report

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
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-734-30	Aripiprazole	30 in 1 BOTTLE	TABLET	30		8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43598-734-30	EA - Each	43598-734	9cbbf2de-a01e-43b3-a633-79c32e5bedb2	1	2018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-734	ARIPIPRAZOLE (ARIPIPRAZOLE ORALLY DISINTEGRATING) TABLET [DR. REDDY'S LABORATORIES INC]	7	Current NDC, Legacy NDC, 1 package rows	20240828_394ea4a4-3991-4f98-b38f-56e9335d66b3.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE ORALLY DISINTEGRATING	Dr. Reddy's Laboratories Inc	394ea4a4-3991-4f98-b38f-56e9335d66b3	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207240 application number: ANDA207240 ndc (product): 43598-734
Aripiprazole	ARIPIPRAZOLE ORALLY DISINTEGRATING	ScieGen Pharmaceuticals Inc	4bcfd5a7-bec7-4426-9314-17daaf715cad	2024-11-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207240 application number: ANDA207240

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
643019	ARIPiprazole 10 MG Disintegrating Oral Tablet	PSN	394ea4a4-3991-4f98-b38f-56e9335d66b3	8
643022	ARIPiprazole 15 MG Disintegrating Oral Tablet	PSN	394ea4a4-3991-4f98-b38f-56e9335d66b3	8
643019	aripiprazole 10 MG Disintegrating Oral Tablet	SCD	394ea4a4-3991-4f98-b38f-56e9335d66b3	8
643022	aripiprazole 15 MG Disintegrating Oral Tablet	SCD	394ea4a4-3991-4f98-b38f-56e9335d66b3	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-734-30	43598073430	30 TABLET in 1 BOTTLE (43598-734-30)	30 tablet	2018-05-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Aripiprazole	Dr. Reddy's Laboratories Inc \| ScieGen Pharmaceuticals Inc	2026-07-21	HUMAN PRESCRIPTION DRUG LABEL	9