Ondansetron Hydrochloride

Product NDC
0527-1726
11-digit product format
005271726
Labeler code
0527
Product ID
0527-1726_c112a6aa-0321-4e6d-ab59-2212f27e6bb0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Lannett Company, Inc.
Application
ANDA090116
Marketing category
ANDA
Marketing start
2010-07-01
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
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0527-1726-40005271726401 VIAL, MULTI-DOSE in 1 CARTON (0527-1726-40) > 20 mL in 1 VIAL, MULTI-DOSE2010-07-010000-00-00NoNoCurrent
0527-1726-41005271726415 VIAL, SINGLE-DOSE in 1 CARTON (0527-1726-41) > 2 mL in 1 VIAL, SINGLE-DOSE2010-07-010000-00-00NoNoCurrent