Aripiprazole

Product NDC: 70518-3090
Requested package NDC: 70518-3090-0
11-digit product format: 705183090
Labeler code: 70518
Product ID: 70518-3090_4e9166bd-b9e4-2c8a-e063-6294a90aea1b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: TABLET
Route: ORAL
Labeler: REMEDYREPACK INC.
Application: ANDA207105
Marketing category: ANDA
Marketing start: 2021-05-10
Substance: ARIPIPRAZOLE
Active strength: 2 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A207105-001	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	2019-02-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-002	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	2019-02-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-003	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	2019-02-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-004	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	2019-02-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-005	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	2019-02-21	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-006	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	2019-02-21	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A207105-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	A207105-006	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 25 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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	REMEDYREPACK INC.	6f580e75-61ab-4c7b-bb3f-f027a9603f84	2026-04-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105 ndc (package): 70518-3090-0 ndc (product): 70518-3090 ndc11 (package): 70518309000
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	REMEDYREPACK INC.	1d593ada-256d-4dec-9a26-2a6a67d97205	2026-02-13	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
Aripiprazole	ARIPIPRAZOLE	Preferred Pharmaceuticals, Inc.	4894031e-639e-49d8-927a-76d684bf6655	2025-01-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 207105 application number: ANDA207105

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE	2 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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
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
6f580e75-61ab-4c7b-bb3f-f027a9603f84	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
70518-3090-0	Aripiprazole	30 in 1 BLISTER PACK	TABLET	30		9
70518-3090-1	Aripiprazole	30 in 1 BOTTLE, PLASTIC	TABLET	30		9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
70518-3090-0	EA - Each	70518-3090	95a1e5c4-38e9-4ff8-b62e-a04344e82820	1	2023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70518-3090	ARIPIPRAZOLE TABLET [REMEDYREPACK INC.]	5	Current NDC, Legacy NDC, 2 package rows	20250523_6f580e75-61ab-4c7b-bb3f-f027a9603f84.zip

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
602964	ARIPiprazole 2 MG Oral Tablet	PSN	6f580e75-61ab-4c7b-bb3f-f027a9603f84	9
602964	aripiprazole 2 MG Oral Tablet	SCD	6f580e75-61ab-4c7b-bb3f-f027a9603f84	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
70518-3090-0	70518309000	30 TABLET in 1 BLISTER PACK (70518-3090-0)	30 tablet	2021-05-10	0000-00-00	No	No	Current