Ondansetron Hydrochloride

Product NDC
67457-440
11-digit product format
674570440
Labeler code
67457
Product ID
67457-440_361871f4-c39b-40bf-8287-061b10d1e191
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Mylan Institutional LLC
Application
ANDA079224
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
67457-440-00ML - Milliliter67457-440ab5edd66-6df5-4745-b3e1-3b6d0bf94a7412017-08-11
67457-440-22ML - Milliliter67457-44040f9951b-247d-42ec-b126-b2b579d2d08012015-02-02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67457-440-226745704402225 VIAL, SINGLE-DOSE in 1 CARTON (67457-440-22) > 2 mL in 1 VIAL, SINGLE-DOSE (67457-440-00) 2014-12-290000-00-00NoNoCurrent