Abilify Asimtufii

Product NDC: 59148-114
11-digit product format: 591480114
Labeler code: 59148
Product ID: 59148-114_284a898a-06c2-4ef9-9cb9-5d3e6cf94f9c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Aripiprazole
Dosage form: INJECTION, SUSPENSION, EXTENDED RELEASE
Route: INTRAMUSCULAR
Labeler: Otsuka America Pharmaceutical, Inc
Application: NDA217006
Marketing category: NDA
Marketing start: 2023-04-27
Substance: ARIPIPRAZOLE
Active strength: 960 mg/3.2mL
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
N217006-001	ABILIFY ASIMTUFII	ARIPIPRAZOLE	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2023-04-27
N217006-002	ABILIFY ASIMTUFII	ARIPIPRAZOLE	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2023-04-27

Orange Book patents#

Current patent rows page 1 of 1 · 16 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25
N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25
N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25
N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25
N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25
N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25
N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24
N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24
N217006-002	10517951	2033-04-23	U-3245	Drug product	2023-05-25
N217006-002	10517951	2033-04-23	U-814	Drug product	2023-05-25
N217006-002	11097007	2033-04-23	U-3245	Drug product	2023-05-25
N217006-002	11097007	2033-04-23	U-814	Drug product	2023-05-25
N217006-002	11638757	2033-04-23	U-3245	Drug product	2023-05-25
N217006-002	11638757	2033-04-23	U-814	Drug product	2023-05-25
N217006-002	12016927	2033-04-23	U-3245	Drug product	2024-07-24
N217006-002	12016927	2033-04-23	U-543	Drug product	2024-07-24

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	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD	2023-04-27	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		RLD, RS	2023-04-27	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	10517951	2033-04-23	U-814	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	11097007	2033-04-23	U-814	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	11638757	2033-04-23	U-814	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	12016927	2033-04-23	U-543	Drug product	2024-07-24	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N217006-002	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Abilify Asimtufii	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc	da4c07fd-1130-4341-bb44-63acfa4162be	2025-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 217006 application number: NDA217006 ndc (product): 59148-114

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE	960 mg/3.2mL

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 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2636637	Internal RxNorm lookup
2636640	Internal RxNorm lookup
2636645	Internal RxNorm lookup
2636646	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
da4c07fd-1130-4341-bb44-63acfa4162be	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
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
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
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
59148-114-80	Abilify Asimtufii	3.2 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	3.2	6
59148-114-80	Abilify Asimtufii	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	6
59148-114-92	Abilify Asimtufii	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1	6
59148-114-92	Abilify Asimtufii	3.2 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	3.2	6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-114-80	ML - Milliliter	59148-114	f7f65b51-590c-4ec6-9efb-a6f84cd45a5f	1	2023-06-06
59148-114-92	ML - Milliliter	59148-114	194d4bcb-e2f4-4f09-8d08-c7a72c886236	1	2024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-114	ABILIFY ASIMTUFII (ARIPIPRAZOLE) INJECTION, SUSPENSION, EXTENDED RELEASE [OTSUKA AMERICA PHARMACEUTICAL, INC]	6	Current NDC, 4 package rows	20250410_da4c07fd-1130-4341-bb44-63acfa4162be.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
2636640	Abilify Asimtufii 720 MG in 2.4 ML Extended Release Prefilled Syringe	PSN	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636646	Abilify Asimtufii 960 MG in 3.2 ML Extended Release Prefilled Syringe	PSN	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636637	ARIPiprazole 720 MG in 2.4 ML Extended Release Prefilled Syringe	PSN	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636645	ARIPiprazole 960 MG in 3.2 ML Extended Release Prefilled Syringe	PSN	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636640	2.4 ML aripiprazole 300 MG/ML Prefilled Syringe [Abilify]	SBD	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636646	3.2 ML aripiprazole 300 MG/ML Prefilled Syringe [Abilify]	SBD	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636637	2.4 ML aripiprazole 300 MG/ML Prefilled Syringe	SCD	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636645	3.2 ML aripiprazole 300 MG/ML Prefilled Syringe	SCD	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636640	2.4 ML Abilify 300 MG/ML Prefilled Syringe	SY	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636646	3.2 ML Abilify 300 MG/ML Prefilled Syringe	SY	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636640	Abilify Asimtufii 720 MG per 2.4 ML extended release Prefilled Syringe	SY	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636646	Abilify Asimtufii 960 MG per 3.2 ML extended release Prefilled Syringe	SY	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636637	aripiprazole 720 MG per 2.4 ML extended release Prefilled Syringe	SY	da4c07fd-1130-4341-bb44-63acfa4162be	6
2636645	aripiprazole 960 MG per 3.2 ML extended release Prefilled Syringe	SY	da4c07fd-1130-4341-bb44-63acfa4162be	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
59148-114-80	59148011480	1 SYRINGE in 1 CARTON (59148-114-80) / 3.2 mL in 1 SYRINGE	1 syringe	2023-04-27	No	No	Current
59148-114-92	59148011492	1 SYRINGE in 1 CARTON (59148-114-92) / 3.2 mL in 1 SYRINGE	1 syringe	2023-04-27	Yes	No	Current