FDA.reportPublic FDA data

ABILIFY

Product NDC
59148-016
11-digit product format
591480016
Labeler code
59148
Product ID
59148-016_9e8f76af-6b2e-5349-e053-2a95a90adcdd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ARIPIPRAZOLE
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR
Labeler
Otsuka America Pharmaceutical, Inc.
Application
NDA021866
Marketing category
NDA
Marketing start
2006-09-20
Marketing end
0000-00-00
Substance
ARIPIPRAZOLE
Active strength
10 mg/1.3mL
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct59148-016DDiscontinued by firm2026-07-31
excluded packagepackage59148-01659148-016-65DDiscontinued by firm2026-07-31

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021866-001ABILIFYARIPIPRAZOLE9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N021866-001ABILIFY9.75MG/1.3ML (7.5MG/ML)INJECTABLE / INTRAMUSCULAR2006-09-20a50c72e98297…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59148-016-65ML - Milliliter59148-0169949e707-04bb-4028-8eb7-0cdce86e2ccb12012-07-24