ONDANSETRON

Product NDC
52959-425
11-digit product format
529590425
Labeler code
52959
Product ID
52959-425_5fb211f6-c675-4dea-e053-2a91aa0ac51a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
H. J. Harkins Company Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2017-01-03
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
52959-425-10ONDANSETRON10 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING101
52959-425-20ONDANSETRON20 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING201
52959-425-30ONDANSETRON30 in 1 CONTAINERTABLET, ORALLY DISINTEGRATING301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-425-10EA - Each52959-425d5350296-5166-4925-98fb-e1ae87225bc712017-12-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-425ONDANSETRON TABLET, ORALLY DISINTEGRATING [H. J. HARKINS COMPANY INC.]1Legacy NDC, 3 package rows20171208_5fb211f6-c674-4dea-e053-2a91aa0ac51a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN5fb211f6-c674-4dea-e053-2a91aa0ac51a1
104894ondansetron 4 MG Disintegrating Oral TabletSCD5fb211f6-c674-4dea-e053-2a91aa0ac51a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-425-105295904251010 in 1 CONTAINERHistorical
52959-425-205295904252020 in 1 CONTAINERHistorical
52959-425-305295904253030 in 1 CONTAINERHistorical