FDA.reportPublic FDA data

Aloxi

Product NDC
62856-798
11-digit product format
628560798
Labeler code
62856
Product ID
62856-798_afcfa291-df05-4e5a-9976-87b0cc8bd378
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palonosetron hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Eisai Inc.
Application
NDA021372
Marketing category
NDA
Marketing start
2014-05-28
Marketing end
2022-10-31
Substance
PALONOSETRON HYDROCHLORIDE
Active strength
0 mg/1.5mL
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
0000-00-00
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 productproduct62856-798DDiscontinued by firm2026-07-31
excluded packagepackage62856-79862856-798-01DDiscontinued 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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021372-001ALOXIPALONOSETRON HYDROCHLORIDEEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2003-07-25
N021372-002ALOXIPALONOSETRON HYDROCHLORIDEEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2008-02-29

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 22:54:322026-06N021372-001ALOXIEQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2003-07-25a50c72e98297…
2026-08-01 22:54:322026-06N021372-002ALOXIEQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2008-02-29a50c72e98297…

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
palonosetron hydrochloridePALONOSETRON HYDROCHLORIDECipla USA Inc.37e7ef89-fd77-44e0-9271-ae91f88226032022-01-13Warnings, Adverse reactionsExact identifier
application applno (NDA): 021372
application number: NDA021372

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
62856-798-012020-12-28C16284748780-19d75b9cf-f42b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALOXI safely and effectively. See full prescribing information for ALOXI ALOXI ® (palonosetron HCl) Injection for Intravenous Use Initial U.S. Approval: 2003
62856-798-012020-01-31C16284748780-19d75b9cf-f42b-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALOXI safely and effectively. See full prescribing information for ALOXI ALOXI ® (palonosetron HCl) Injection for Intravenous Use Initial U.S. Approval: 2003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PALONOSETRON HYDROCHLORIDEACTIVE INGREDIENT23310D4I19ALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]14
PALONOSETRONACTIVE MOIETY5D06587D6RALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]14
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]14
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]14
MANNITOLINACTIVE INGREDIENT3OWL53L36AALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]14
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]14
WATERINACTIVE INGREDIENT059QF0KO0RALOXI (PALONOSETRON HYDROCHLORIDE) INJECTION [EISAI INC.]14