Ondansetron

Product NDC
50090-1201
11-digit product format
500901201
Labeler code
50090
Product ID
50090-1201_b5faf670-f22b-4d1a-bb78-31b59d136d2f
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
4 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

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
50090-1201-0Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING1016
50090-1201-0Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING116

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1201-0EA - Each50090-1201a92d51bb-8482-4624-8645-cc772bd7d93b12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1201ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]16Current NDC, Legacy NDC, 2 package rows20231024_251d7b9a-f935-42f7-b985-91b8bba7637b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN251d7b9a-f935-42f7-b985-91b8bba7637b16
104894ondansetron 4 MG Disintegrating Oral TabletSCD251d7b9a-f935-42f7-b985-91b8bba7637b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1201-0500901201001 BLISTER PACK in 1 CARTON (50090-1201-0) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2014-11-280000-00-00NoNoCurrent