FDA.reportPublic FDA data

Ondansetron

Product NDC
76420-217
11-digit product format
764200217
Labeler code
76420
Product ID
76420-217_2eaaa08a-db13-8991-e063-6294a90ac450
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Asclemed USA, Inc.
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, 312087

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
76420-217-04Ondansetron4 in 1 BOTTLETABLET, ORALLY DISINTEGRATING43
76420-217-06Ondansetron6 in 1 BOTTLETABLET, ORALLY DISINTEGRATING63
76420-217-10Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING103
76420-217-20Ondansetron20 in 1 BOTTLETABLET, ORALLY DISINTEGRATING203
76420-217-30Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING33
76420-217-30Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-217-04EA - Each76420-217bfe6d1b7-0e56-4c35-847f-0986729a1b1c12022-09-12
76420-217-06EA - Each76420-217413ec2b3-1f75-4b05-87e5-9c207712cd4112022-09-12
76420-217-10EA - Each76420-217bf844e41-ec08-4b05-a4d3-f9db90ebe08412022-09-12
76420-217-20EA - Each76420-217fab03068-cb2d-4236-b05c-688ec8b4935312022-09-12
76420-217-30EA - Each76420-2173aa0c5f0-bd71-4edb-a425-280353216cea12022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-217ONDANSETRON TABLET, ORALLY DISINTEGRATING [ASCLEMED USA, INC.]3Current NDC, Legacy NDC, 6 package rows20250228_e436e361-da0f-7d6d-e053-2995a90a10e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletPSNe436e361-da0f-7d6d-e053-2995a90a10e43
104894ondansetron 4 MG Disintegrating Oral TabletSCDe436e361-da0f-7d6d-e053-2995a90a10e43
312087ondansetron 8 MG Disintegrating Oral TabletSCDe436e361-da0f-7d6d-e053-2995a90a10e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-217-04764200217044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-217-04) 2022-07-200000-00-00NoNoCurrent
76420-217-06764200217066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-217-06) 2022-07-200000-00-00NoNoCurrent
76420-217-107642002171010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-217-10) 2022-07-200000-00-00NoNoCurrent
76420-217-207642002172020 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-217-20) 2022-07-200000-00-00NoNoCurrent
76420-217-30764200217303 BLISTER PACK in 1 CARTON (76420-217-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2022-07-200000-00-00NoNoCurrent