FDA.reportPublic FDA data

Ondansetron

Product NDC
50090-1128
11-digit product format
500901128
Labeler code
50090
Product ID
50090-1128_e75d99fb-9d40-4f74-94d6-0e9b5e7a521b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894, 312087

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1128-0Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING139
50090-1128-0Ondansetron4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING439
50090-1128-1Ondansetron30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING3039
50090-1128-1Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING139
50090-1128-2Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING139
50090-1128-2Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1039
50090-1128-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1039
50090-1128-3Ondansetron2 in 1 CARTONTABLET, ORALLY DISINTEGRATING239

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1128-0EA - Each50090-11285395e08e-423e-45e0-9027-c50f659bbbfc12025-01-14
50090-1128-1EA - Each50090-11289b9d01ed-f1e5-4aa1-9a4e-e4fbe0bca40812025-06-13
50090-1128-2EA - Each50090-1128343a205b-7421-4520-b4ac-3f34a0e1530412024-12-10
50090-1128-3EA - Each50090-112822dff84b-8a35-453d-8f26-76cf9eadc75312025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1128ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]36Current NDC, Legacy NDC, 8 package rows20250516_378d0963-d026-4478-8202-fbb636904a37.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN378d0963-d026-4478-8202-fbb636904a3739
312087ondansetron 8 MG Disintegrating Oral TabletPSN378d0963-d026-4478-8202-fbb636904a3739
104894ondansetron 4 MG Disintegrating Oral TabletSCD378d0963-d026-4478-8202-fbb636904a3739
312087ondansetron 8 MG Disintegrating Oral TabletSCD378d0963-d026-4478-8202-fbb636904a3739

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1128-0500901128001 BLISTER PACK in 1 CARTON (50090-1128-0) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2014-11-280000-00-00NoNoCurrent
50090-1128-1500901128011 BLISTER PACK in 1 CARTON (50090-1128-1) / 30 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2014-11-280000-00-00NoNoCurrent
50090-1128-2500901128021 BLISTER PACK in 1 CARTON (50090-1128-2) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2014-11-280000-00-00NoNoCurrent
50090-1128-3500901128032 BLISTER PACK in 1 CARTON (50090-1128-3) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2025-05-01NoNoHistorical