ondansetron hydrochloride

Product NDC
82449-201
11-digit product format
824490201
Labeler code
82449
Product ID
82449-201_e83dfff2-ddb9-562a-e053-2995a90aa7a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Steriscience Specialties Private Limited
Application
ANDA078257
Marketing category
ANDA
Marketing start
2017-12-31
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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82449-201ONDANSETRON HYDROCHLORIDE INJECTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]3Legacy NDC20230930_75e45d4e-9bf7-46ab-a83b-3dcbf5098eda.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82449-201-01824490201011 VIAL, MULTI-DOSE in 1 CARTON (82449-201-01) > 20 mL in 1 VIAL, MULTI-DOSE2017-12-310000-00-00NoNoCurrent