Palonosetron Hydrochloride

Product NDC
0409-2504
11-digit product format
004092504
Labeler code
0409
Product ID
0409-2504_91412b10-62b2-446b-9459-725e1ae7bcaa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
PALONOSETRON HYDROCHLORIDE
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Hospira, Inc.
Application
ANDA207005
Marketing category
ANDA
Marketing start
2018-11-14
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
0409-2504-10ML - Milliliter0409-2504b44d90ef-76e1-4c38-a837-05ddde117f3d12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0409-2504PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]5Legacy NDC20240511_dff05900-7d15-424d-bf95-b7b60869fa97.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-2504-10004092504101 VIAL, SINGLE-DOSE in 1 CARTON (0409-2504-10) > 5 mL in 1 VIAL, SINGLE-DOSE2018-11-140000-00-00NoNoCurrent