Palonosetron hydrochloride

Product NDC
69543-371
11-digit product format
695430371
Labeler code
69543
Product ID
69543-371_69323708-48a3-4f29-8e92-2c6e010093fe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Palonosetron hydrochloride
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Virtus Pharmaceuticals, LLC
Application
ANDA209287
Marketing category
ANDA
Marketing start
2018-09-19
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69543-371-01ML - Milliliter69543-3717fa243d9-5772-419f-a85d-ada643c436da12018-10-11
69543-371-10ML - Milliliter69543-3717046c8d9-bea3-42dd-9bff-a39597145ab412018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69543-371PALONOSETRON HYDROCHLORIDE INJECTION, SOLUTION [VIRTUS PHARMACEUTICALS, LLC]4Legacy NDC20231102_ba2ece34-a3da-420d-a79c-4e53d11af5f3.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69543-371-106954303711010 CARTON in 1 BOX (69543-371-10) > 1 VIAL in 1 CARTON (69543-371-01) > 5 mL in 1 VIAL10 carton2018-09-190000-00-00NoNoCurrent