ONDANSETRON

Product NDC
51662-1246
11-digit product format
516621246
Labeler code
51662
Product ID
51662-1246_2b3800d9-18fc-7f5d-e063-6294a90a7a3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA090469
Marketing category
ANDA
Marketing start
2018-11-19
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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51662-1246-4ONDANSETRON4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING45
51662-1246-4ONDANSETRON1 in 1 BAGTABLET, ORALLY DISINTEGRATING15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51662-1246ONDANSETRON TABLET, ORALLY DISINTEGRATING [HF ACQUISITION CO LLC, DBA HEALTHFIRST]5Current NDC, Legacy NDC, 2 package rows20250110_7b062fa9-e004-23d5-e053-2a91aa0a20cd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN7b062fa9-e004-23d5-e053-2a91aa0a20cd5
104894ondansetron 4 MG Disintegrating Oral TabletSCD7b062fa9-e004-23d5-e053-2a91aa0a20cd5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51662-1246-4516621246041 BLISTER PACK in 1 BAG (51662-1246-4) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2018-11-190000-00-00NoNoCurrent