FDA.reportPublic FDA data

Ondansetron

Product NDC
50090-2343
11-digit product format
500902343
Labeler code
50090
Product ID
50090-2343_8838975c-69a6-481a-9c2b-7139e3c79ced
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
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2343-0Ondansetron10 in 1 CARTONTABLET, ORALLY DISINTEGRATING102
50090-2343-0Ondansetron1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
50090-2343-1Ondansetron1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
50090-2343-1Ondansetron20 in 1 CARTONTABLET, ORALLY DISINTEGRATING202
50090-2343-2Ondansetron1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
50090-2343-2Ondansetron5 in 1 CARTONTABLET, ORALLY DISINTEGRATING52
50090-2343-3Ondansetron1 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING12
50090-2343-3Ondansetron30 in 1 CARTONTABLET, ORALLY DISINTEGRATING302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2343-0EA - Each50090-234361b6af41-aeef-42c1-a2cf-b89ad78e627912023-06-06
50090-2343-1EA - Each50090-2343d29f06c3-d4aa-44af-8276-22d0797e8a0c12023-06-06
50090-2343-2EA - Each50090-23437a8b0fd9-3b56-4f36-84a3-5263aaadc51512023-06-06
50090-2343-3EA - Each50090-234399c1cdaf-38e8-4431-9a27-d1971b2b8c0b12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2343ONDANSETRON TABLET, ORALLY DISINTEGRATING [A-S MEDICATION SOLUTIONS]2Current NDC, 8 package rows20230517_ad92ffb6-dc63-48dc-9fcc-37fd3d42a75c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNad92ffb6-dc63-48dc-9fcc-37fd3d42a75c2
104894ondansetron 4 MG Disintegrating Oral TabletSCDad92ffb6-dc63-48dc-9fcc-37fd3d42a75c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-2343-05009023430010 BLISTER PACK in 1 CARTON (50090-2343-0) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK10 blister pack2016-04-06NoNoCurrent
50090-2343-15009023430120 BLISTER PACK in 1 CARTON (50090-2343-1) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK20 blister pack2016-04-06NoNoCurrent
50090-2343-2500902343025 BLISTER PACK in 1 CARTON (50090-2343-2) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK5 blister pack2016-04-06NoNoCurrent
50090-2343-35009023430330 BLISTER PACK in 1 CARTON (50090-2343-3) / 1 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK30 blister pack2019-04-04NoNoCurrent