Palonosetron hydrochloride

Product NDC
69097-439
11-digit product format
690970439
Labeler code
69097
Product ID
69097-439_6d581638-ccce-4326-b306-e1e6372979aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonsetron hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Cipla USA Inc.
Application
ANDA206396
Marketing category
ANDA
Marketing start
2021-10-10
Marketing end
0000-00-00
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-439-35ML - Milliliter69097-439ed1f58af-81ec-4f17-8024-64097f466c6012019-04-11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69097-439-35690970439351 VIAL, SINGLE-USE in 1 CARTON (69097-439-35) > 5 mL in 1 VIAL, SINGLE-USE2019-03-250000-00-00NoNoCurrent