ondansetron hydrochloride

Product NDC
82449-200
11-digit product format
824490200
Labeler code
82449
Product ID
82449-200_e83dddc5-d68c-a93e-e053-2a95a90ad644
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Steriscience Specialties Private Limited
Application
ANDA078244
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
82449-200ONDANSETRON HYDROCHLORIDE INJECTION [STERISCIENCE SPECIALTIES PRIVATE LIMITED]3Legacy NDC20230930_01d69f4d-eddf-4fc8-820b-832f11f2e3c0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
82449-200-038244902000325 VIAL, SINGLE-DOSE in 1 CARTON (82449-200-03) > 2 mL in 1 VIAL, SINGLE-DOSE (82449-200-01) 2017-12-310000-00-00NoNoCurrent