Ondansetron

Product NDC
71205-109
11-digit product format
712050109
Labeler code
71205
Product ID
71205-109_77fb2d29-c2fc-4e01-b124-7fb7ddbd533b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
SOLUTION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA091342
Marketing category
ANDA
Marketing start
2011-01-27
Marketing end
0000-00-00
Substance
ONDANSETRON HYDROCHLORIDE
Active strength
4 mg/5mL
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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-109-50ML - Milliliter71205-109654dc9e6-77f8-428b-9839-d8a14c58c8a012018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-109ONDANSETRON (ONDANSETRON HYDROCHLORIDE) SOLUTION [PROFICIENT RX LP]5Legacy NDC20221104_c2ae1141-4b73-469f-a14b-f1a52628c2d2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71205-109-507120501095050 mL in 1 BOTTLE, PLASTIC (71205-109-50) 50 ml2018-09-040000-00-00NoNoCurrent