ondansetron

Product NDC
50090-5346
11-digit product format
500905346
Labeler code
50090
Product ID
50090-5346_01aea742-3c55-4ada-92f0-e361e3aa421e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA077557
Marketing category
ANDA
Marketing start
2007-08-02
Marketing end
0000-00-00
Substance
ONDANSETRON
Active strength
8 mg/1
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
50090-5346-0EA - Each50090-53468cea798d-9e9f-44b4-b179-4bb6fc51223912022-12-07
50090-5346-1EA - Each50090-5346820b30ae-904c-44e0-8f62-f993a25e9f6b12022-04-06
50090-5346-2EA - Each50090-534688b9c411-3398-4c87-9d38-7b1c904af2a812022-12-07
50090-5346-3EA - Each50090-5346a4669889-ab56-4ece-9939-f884e1f51dc312022-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5346ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]8Legacy NDC20231217_665cc265-91f1-4cc1-b4c9-2097314538c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5346-0500905346004 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (50090-5346-0) 2020-11-060000-00-00NoNoCurrent
50090-5346-1500905346013 BLISTER PACK in 1 DOSE PACK (50090-5346-1) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2020-11-060000-00-00NoNoCurrent
50090-5346-2500905346021 BLISTER PACK in 1 DOSE PACK (50090-5346-2) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2020-11-060000-00-00NoNoCurrent
50090-5346-3500905346032 BLISTER PACK in 1 DOSE PACK (50090-5346-3) > 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2020-11-110000-00-00NoNoCurrent