ABILIFY

Product NDC: 63629-3387
11-digit product format: 636293387
Labeler code: 63629
Product ID: 63629-3387_20f05298-1084-4bb6-88a6-ef225d995471
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ARIPIPRAZOLE
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: NDA021436
Marketing category: NDA
Marketing start: 2002-11-15
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 5 mg/1
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2020-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63629-3387		D	Discontinued by firm	2026-07-31
excluded package	package	63629-3387	63629-3387-1	D	Discontinued by firm	2026-07-31
excluded package	package	63629-3387	63629-3387-2	D	Discontinued by firm	2026-07-31
excluded package	package	63629-3387	63629-3387-3	D	Discontinued by firm	2026-07-31
excluded package	package	63629-3387	63629-3387-4	D	Discontinued by firm	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63629-3387-1	EA - Each	63629-3387	f85ddd01-350d-44a3-a75a-3d5b45b79da8	1	2013-02-13
63629-3387-2	EA - Each	63629-3387	6d1b08ed-a415-4f3a-a85c-577ee73cf5ef	1	2013-02-13
63629-3387-3	EA - Each	63629-3387	a5406227-9543-4a13-ace6-27711a664d88	1	2013-02-13
63629-3387-4	EA - Each	63629-3387	a7ecacda-0cfc-4485-b102-8bb8dd3fae35	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ARIPIPRAZOLE	ACTIVE INGREDIENT	82VFR53I78	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
ARIPIPRAZOLE	ACTIVE MOIETY	82VFR53I78	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	ABILIFY (ARIPIPRAZOLE) TABLET [BRYANT RANCH PREPACK]	1000