ABILIFY

Product NDC: 21695-005
11-digit product format: 216950005
Labeler code: 21695
Product ID: 21695-005_217e52b5-3a7b-4bbe-af3c-b18de7d426c3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ARIPIPRAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: Rebel Distributors Corp.
Application: NDA021436
Marketing category: NDA
Marketing start: 2002-11-15
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 20 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	21695-005		I	Inactivated by FDA		2026-07-31
excluded package	package	21695-005	21695-005-30	I	Inactivated by FDA		2026-07-31

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	RLD / RS	Approval date
N021436-001	ABILIFY	ARIPIPRAZOLE	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15
N021436-002	ABILIFY	ARIPIPRAZOLE	15MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-003	ABILIFY	ARIPIPRAZOLE	20MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-004	ABILIFY	ARIPIPRAZOLE	30MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-005	ABILIFY	ARIPIPRAZOLE	5MG	TABLET / ORAL	AB	RLD	2002-11-15
N021436-006	ABILIFY	ARIPIPRAZOLE	2MG	TABLET / ORAL	AB	RLD	2002-11-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021436-001	AB
N021436-002	AB
N021436-003	AB
N021436-004	AB
N021436-005	AB
N021436-006	AB

Orange Book patents#

Current patent rows page 1 of 1 · 12 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Submission date
N021436-001	9125939	2026-07-28	U-1749	2015-10-07
N021436-001	8759350	2027-03-02	U-1529	2014-07-22
N021436-002	9125939	2026-07-28	U-1749	2015-10-07
N021436-002	8759350	2027-03-02	U-1529	2014-07-22
N021436-003	9125939	2026-07-28	U-1749	2015-10-07
N021436-003	8759350	2027-03-02	U-1529	2014-07-22
N021436-004	9125939	2026-07-28	U-1749	2015-10-07
N021436-004	8759350	2027-03-02	U-1529	2014-07-22
N021436-005	9125939	2026-07-28	U-1749	2015-10-07
N021436-005	8759350	2027-03-02	U-1529	2014-07-22
N021436-006	9125939	2026-07-28	U-1749	2015-10-07
N021436-006	8759350	2027-03-02	U-1529	2014-07-22

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	N021436-001	ABILIFY	10MG	TABLET / ORAL	AB	RLD, RS	2002-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-002	ABILIFY	15MG	TABLET / ORAL	AB	RLD	2002-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-003	ABILIFY	20MG	TABLET / ORAL	AB	RLD	2002-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-004	ABILIFY	30MG	TABLET / ORAL	AB	RLD	2002-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-005	ABILIFY	5MG	TABLET / ORAL	AB	RLD	2002-11-15	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-006	ABILIFY	2MG	TABLET / ORAL	AB	RLD	2002-11-15	`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	N021436-001	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-002	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-003	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-004	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-005	AB	1	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-006	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Submission date	Source SHA-256
2026-08-01 22:54:32	2026-06	N021436-001	9125939	2026-07-28	U-1749	2015-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-001	8759350	2027-03-02	U-1529	2014-07-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-002	9125939	2026-07-28	U-1749	2015-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-002	8759350	2027-03-02	U-1529	2014-07-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-003	9125939	2026-07-28	U-1749	2015-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-003	8759350	2027-03-02	U-1529	2014-07-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-004	9125939	2026-07-28	U-1749	2015-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-004	8759350	2027-03-02	U-1529	2014-07-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-005	9125939	2026-07-28	U-1749	2015-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-005	8759350	2027-03-02	U-1529	2014-07-22	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-006	9125939	2026-07-28	U-1749	2015-10-07	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N021436-006	8759350	2027-03-02	U-1529	2014-07-22	`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	ARIPIPRAZOLE	Otsuka America Pharmaceutical, Inc.	c040bd1d-45b7-49f2-93ea-aed7220b30ac	2025-01-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021436 application number: NDA021436

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-005-30	2019-09-24	C162847	48780-1	934fe258-4902-48b1-e053-8cdaa90a720a	These highlights do not include all the information needed to use ABILIFY safely and effectively. See full prescribing information for ABILIFY. ABILIFY ® (aripiprazole) Tablets ABILIFY DISCMELT ® (aripiprazole) Orally Disintegrating Tablets ABILIFY ® (aripiprazole) Oral Solution ABILIFY ® (aripiprazole) Injection FOR INTRAMUSCULAR USE ONLY Initial U.S. Approval: 2002

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
21695-005-30	ABILIFY	30 in 1 BOTTLE, PLASTIC	TABLET	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-005-30	EA - Each	21695-005	7892fc4b-df03-4e6b-85ea-3b340615e1ea	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARIPIPRAZOLE	ACTIVE INGREDIENT	82VFR53I78	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
ARIPIPRAZOLE	ACTIVE MOIETY	82VFR53I78	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-005	ABILIFY (ARIPIPRAZOLE) TABLET [REBEL DISTRIBUTORS CORP.]	1	Legacy NDC, 1 package rows	20100907_217e52b5-3a7b-4bbe-af3c-b18de7d426c3.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
352307	ABILIFY 10 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352308	ABILIFY 15 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352309	ABILIFY 20 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
404602	ABILIFY 5 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
349545	ARIPiprazole 10 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
349490	ARIPiprazole 15 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
349553	ARIPiprazole 20 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
402131	ARIPiprazole 5 MG Oral Tablet	PSN	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352307	aripiprazole 10 MG Oral Tablet [Abilify]	SBD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352308	aripiprazole 15 MG Oral Tablet [Abilify]	SBD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352309	aripiprazole 20 MG Oral Tablet [Abilify]	SBD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
404602	aripiprazole 5 MG Oral Tablet [Abilify]	SBD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
349545	aripiprazole 10 MG Oral Tablet	SCD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
349490	aripiprazole 15 MG Oral Tablet	SCD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
349553	aripiprazole 20 MG Oral Tablet	SCD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
402131	aripiprazole 5 MG Oral Tablet	SCD	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352307	Abilify 10 MG Oral Tablet	SY	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352308	Abilify 15 MG Oral Tablet	SY	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
352309	Abilify 20 MG Oral Tablet	SY	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1
404602	Abilify 5 MG Oral Tablet	SY	217e52b5-3a7b-4bbe-af3c-b18de7d426c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-005-30	21695000530	30 in 1 BOTTLE, PLASTIC	Historical