ABILIFY

Product NDC: 59148-013
11-digit product format: 591480013
Labeler code: 59148
Product ID: 59148-013_9e8f76af-6b2e-5349-e053-2a95a90adcdd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ARIPIPRAZOLE
Dosage form: SOLUTION
Route: ORAL
Labeler: Otsuka America Pharmaceutical, Inc.
Application: NDA021713
Marketing category: NDA
Marketing start: 2004-12-10
Marketing end: 0000-00-00
Substance: ARIPIPRAZOLE
Active strength: 1 mg/mL
Pharmacologic classes: Atypical Antipsychotic [EPC]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	59148-013		D	Discontinued by firm		2026-07-31
excluded package	package	59148-013	59148-013-15	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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021713-001	ABILIFY	ARIPIPRAZOLE	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-12-10

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021713-001	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	N021713-001	ABILIFY	1MG/ML Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	SOLUTION / ORAL		RLD	2004-12-10	`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	N021713-001	8759350	2027-03-02	U-1529		2014-07-22	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59148-013-15	ML - Milliliter	59148-013	21d0b971-2ce1-4539-bfa5-1fbc070e322f	1	2012-07-24