Abilify Asimtufii

Product NDC: 59148-102
11-digit product format: 591480102
Labeler code: 59148
Product ID: 59148-102_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: 720 mg/2.4mL
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 43.

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.

Product history page 1 of 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217006-001	ABILIFY ASIMTUFII	720MG/2.4ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD	2023-04-27	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N217006-002	ABILIFY ASIMTUFII	960MG/3.2ML (300MG/ML)	SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR	RLD, RS	2023-04-27	`a72a2bbeb626…`

Observed Orange Book patent history#

Patent history page 1 of 12 · 444 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-09-14 22:38:34	2026-08	N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	10517951	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11097007	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11638757	2033-04-23	U-814	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	12016927	2033-04-23	U-543	Drug product	2024-07-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N217006-002	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	10517951	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11097007	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11638757	2033-04-23	U-814	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	12016927	2033-04-23	U-543	Drug product	2024-07-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N217006-002	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N217006-001	10517951	2033-04-23	U-3245	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	10517951	2033-04-23	U-814	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11097007	2033-04-23	U-3245	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11097007	2033-04-23	U-814	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11638757	2033-04-23	U-3245	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	11638757	2033-04-23	U-814	Drug product	2023-05-25	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	12016927	2033-04-23	U-3245	Drug product	2024-07-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217006-001	12016927	2033-04-23	U-543	Drug product	2024-07-24	`011fe1cb6892…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ARIPIPRAZOLE	720 mg/2.4mL

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	Strength	SPL version
59148-102-80	Abilify Asimtufii	2.4 mL in 1 SYRINGE	INJECTION, SUSPENSION, EXTENDED	2.4		6
59148-102-80	Abilify Asimtufii	1 in 1 CARTON	INJECTION, SUSPENSION, EXTENDED	1		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-102-80	ML - Milliliter	59148-102	35084241-526a-4d26-a9f8-ab8779a683c4	1	2023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59148-102	ABILIFY ASIMTUFII (ARIPIPRAZOLE) INJECTION, SUSPENSION, EXTENDED RELEASE [OTSUKA AMERICA PHARMACEUTICAL, INC]	6	Current NDC, 2 package rows	20250410_da4c07fd-1130-4341-bb44-63acfa4162be.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
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): 59148-102

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
59148-102-80	59148010280	1 SYRINGE in 1 CARTON (59148-102-80) / 2.4 mL in 1 SYRINGE	1 syringe	2023-04-27	No	No	Current