FDA.reportPublic FDA data

Ondansetron

Product NDC
76420-251
11-digit product format
764200251
Labeler code
76420
Product ID
76420-251_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
8 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
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
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
76420-251-04Ondansetron4 in 1 BOTTLETABLET, ORALLY DISINTEGRATING43
76420-251-06Ondansetron6 in 1 BOTTLETABLET, ORALLY DISINTEGRATING63
76420-251-10Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING103
76420-251-20Ondansetron20 in 1 BOTTLETABLET, ORALLY DISINTEGRATING203
76420-251-30Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING33
76420-251-30Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-251-04EA - Each76420-2514d5783fc-76ba-40c0-8961-28aa3cf1195b12022-09-12
76420-251-06EA - Each76420-2515ec9fb85-eeb1-4d19-a156-7f2eff02e45612022-09-12
76420-251-10EA - Each76420-251b3972183-2483-48a7-8ffa-275dca97139a12022-09-12
76420-251-20EA - Each76420-251217f8949-4609-4e97-bd75-8fddaa800f7f12022-09-12
76420-251-30EA - Each76420-251db1b38ae-793d-4709-94ef-3ef1d92c4e5012022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-251ONDANSETRON 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
76420-251-04764200251044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-04) 2022-07-200000-00-00NoNoCurrent
76420-251-06764200251066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-06) 2022-07-200000-00-00NoNoCurrent
76420-251-107642002511010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-10) 2022-07-200000-00-00NoNoCurrent
76420-251-207642002512020 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (76420-251-20) 2022-07-200000-00-00NoNoCurrent
76420-251-30764200251303 BLISTER PACK in 1 CARTON (76420-251-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2022-07-200000-00-00NoNoCurrent