ALOXI

Product NDC
69639-104
11-digit product format
696390104
Labeler code
69639
Product ID
69639-104_327cc7a4-5261-49cc-9e30-e7fffc9662ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palonosetron hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Helsinn Therapeutics (U.S.), Inc.
Application
NDA022233
Marketing category
NDA
Marketing start
2014-05-28
Marketing end
0000-00-00
Substance
PALONOSETRON HYDROCHLORIDE
Active strength
1 mg/.5mg
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69639-104-052024-12-19C16284748780-1f386c649-e0b2-0266-e053-dadaa90a7c1aab89d423-4275-4651-9ae7-9002f17ab0a1
69639-104-052023-01-30C16284748780-1f386c649-e0b2-0266-e053-dadaa90a7c1aab89d423-4275-4651-9ae7-9002f17ab0a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69639-104-05696390104055 CAPSULE in 1 CARTON (69639-104-05) > .5 mg in 1 CAPSULE5 capsule2014-05-280000-00-00NoNoCurrent