palonosetron hydrochloride

Product NDC
16729-365
11-digit product format
167290365
Labeler code
16729
Product ID
16729-365_c336aa2e-e9b4-392a-e053-2a95a90a9d9f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
palonosetron hydrochloride
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Accord Healthcare, Inc.
Application
NDA021372
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2018-03-23
Marketing end
2022-11-30
Substance
PALONOSETRON HYDROCHLORIDE
Active strength
0 mg/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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-365-66ML - Milliliter16729-365c703bbf1-12e5-4717-8cd1-3b20093c089e12018-04-19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-365-66167290365661 VIAL in 1 CARTON (16729-365-66) > 5 mL in 1 VIAL1 vial2018-03-230000-00-00NoNoCurrent