Ondansetron Hydrochloride

Product NDC
67457-441
11-digit product format
674570441
Labeler code
67457
Product ID
67457-441_17a19022-948e-44b7-ba4d-e0aae1918b28
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA090648
Marketing category
ANDA
Marketing start
2014-12-29
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
2 mg/mL
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
67457-441-20ML - Milliliter67457-44135238ae6-946a-480b-92ad-8518a018910012015-02-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-441-20674570441201 VIAL, MULTI-DOSE in 1 CARTON (67457-441-20) > 20 mL in 1 VIAL, MULTI-DOSE2014-12-290000-00-00NoNoCurrent