Aloxi

Product NDC
69639-103
Requested package NDC
69639-103-05
11-digit product format
696390103
Labeler code
69639
Product ID
69639-103_e440c700-5ea8-6ada-e053-2a95a90a6769
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palonosetron hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Helsinn Therapeutics (U.S.), Inc.
Application
NDA021372
Marketing category
NDA
Marketing start
2018-11-01
Marketing end
2022-11-01
Substance
PALONOSETRON HYDROCHLORIDE
Active strength
0 mg/mL
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69639-10369639-103-05DDiscontinued 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0.25MG BASE/5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2003-07-25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0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**INJECTABLE / INTRAVENOUSRLD2008-02-29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#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69639-103-01ML - Milliliter69639-1039a514cb1-0420-4d14-9c80-f0e34390c5e712019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69639-103-05696390103051 VIAL in 1 CARTON (69639-103-05) > 1.5 mL in 1 VIAL1 vial2018-11-012022-11-01NoNoCurrent