Aripiprazole

Product NDC: 43598-967
11-digit product format: 435980967
Labeler code: 43598
Product ID: 43598-967_5be74c47-c62f-40f5-8aad-bd20f8f4cae3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: Dr.Reddy�s Laboratories Inc
Application: ANDA206383
Marketing category: ANDA
Marketing start: 2020-03-16
Substance: ARIPIPRAZOLE
Active strength: 10 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 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A206383-001	ARIPIPRAZOLE	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29
A206383-002	ARIPIPRAZOLE	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29
A206383-003	ARIPIPRAZOLE	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29
A206383-004	ARIPIPRAZOLE	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29
A206383-005	ARIPIPRAZOLE	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-29
A206383-006	ARIPIPRAZOLE	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206383-001	AB
A206383-002	AB
A206383-003	AB
A206383-004	AB
A206383-005	AB
A206383-006	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	A206383-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206383-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2016-09-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2016-09-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2016-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2016-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2016-09-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2016-09-29	`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	A206383-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-003	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-004	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-005	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A206383-006	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-003	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-004	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-005	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206383-006	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206383-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-003	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-004	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-005	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A206383-006	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-003	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-004	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-005	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206383-006	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-003	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-004	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-005	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206383-006	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-003	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-004	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-005	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206383-006	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-003	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206383-004	AB	1	`2680178bc6a6…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aripiprazole
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE	10 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
349490	Internal RxNorm lookup
349545	Internal RxNorm lookup
349547	Internal RxNorm lookup
349553	Internal RxNorm lookup
402131	Internal RxNorm lookup
602964	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
178f09f0-e08e-452b-b817-717c5c49e110	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43598-967-05	Aripiprazole	500 in 1 BOTTLE	TABLET	500		5
43598-967-30	Aripiprazole	30 in 1 BOTTLE	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43598-967	ARIPIPRAZOLE TABLET [DR.REDDY&RSQUO;S LABORATORIES INC]	4	Current NDC, Legacy NDC, 2 package rows	20240731_178f09f0-e08e-452b-b817-717c5c49e110.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aripiprazole	ARIPIPRAZOLE	Dr.Reddys Laboratories Inc	178f09f0-e08e-452b-b817-717c5c49e110	2025-10-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206383 application number: ANDA206383 ndc (product): 43598-967
Aripiprazole	ARIPIPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	d8183eaf-0093-4720-b8ed-20e570697511	2024-10-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206383 application number: ANDA206383
Aripiprazole	ARIPIPRAZOLE	ScieGen Pharmaceuticals Inc	a7d9d5d1-25ba-4f4e-a990-398c0bf09c7e	2023-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206383 application number: ANDA206383
Aripiprazole	ARIPIPRAZOLE	NCS HealthCare of KY, LLC dba Vangard Labs	8da99c93-613e-4b78-9f91-3efc2dea194d	2022-08-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206383 application number: ANDA206383
Aripiprazole	ARIPIPRAZOLE	Dr.Reddys Laboratories Inc	0aa7e178-456a-4942-93aa-9ec18a58939f	2020-06-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206383 application number: ANDA206383
Aripiprazole	ARIPIPRAZOLE	ScieGen Pharmaceuticals Inc	95954ba3-e838-4dd7-aef1-c51ac6aff76b	2020-05-06	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206383 application number: ANDA206383

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	178f09f0-e08e-452b-b817-717c5c49e110	5
349490	ARIPiprazole 15 MG Oral Tablet	PSN	178f09f0-e08e-452b-b817-717c5c49e110	5
602964	ARIPiprazole 2 MG Oral Tablet	PSN	178f09f0-e08e-452b-b817-717c5c49e110	5
349553	ARIPiprazole 20 MG Oral Tablet	PSN	178f09f0-e08e-452b-b817-717c5c49e110	5
349547	ARIPiprazole 30 MG Oral Tablet	PSN	178f09f0-e08e-452b-b817-717c5c49e110	5
402131	ARIPiprazole 5 MG Oral Tablet	PSN	178f09f0-e08e-452b-b817-717c5c49e110	5
349545	aripiprazole 10 MG Oral Tablet	SCD	178f09f0-e08e-452b-b817-717c5c49e110	5
349490	aripiprazole 15 MG Oral Tablet	SCD	178f09f0-e08e-452b-b817-717c5c49e110	5
602964	aripiprazole 2 MG Oral Tablet	SCD	178f09f0-e08e-452b-b817-717c5c49e110	5
349553	aripiprazole 20 MG Oral Tablet	SCD	178f09f0-e08e-452b-b817-717c5c49e110	5
349547	aripiprazole 30 MG Oral Tablet	SCD	178f09f0-e08e-452b-b817-717c5c49e110	5
402131	aripiprazole 5 MG Oral Tablet	SCD	178f09f0-e08e-452b-b817-717c5c49e110	5
349545	ARIPiprazole 10 MG Oral Tablet	PSN	d8183eaf-0093-4720-b8ed-20e570697511	1
602964	ARIPiprazole 2 MG Oral Tablet	PSN	d8183eaf-0093-4720-b8ed-20e570697511	1
349545	aripiprazole 10 MG Oral Tablet	SCD	d8183eaf-0093-4720-b8ed-20e570697511	1
602964	aripiprazole 2 MG Oral Tablet	SCD	d8183eaf-0093-4720-b8ed-20e570697511	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
43598-967-05	43598096705	500 TABLET in 1 BOTTLE (43598-967-05)	500 tablet	2020-03-16	0000-00-00	No	No	Current
43598-967-30	43598096730	30 TABLET in 1 BOTTLE (43598-967-30)	30 tablet	2020-03-16	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	2025-10-24	HUMAN PRESCRIPTION DRUG LABEL	5
Aripiprazole	NCS HealthCare of KY, LLC dba Vangard Labs	2024-10-25	HUMAN PRESCRIPTION DRUG LABEL	1