Ondansetron

Product NDC
60760-567
11-digit product format
607600567
Labeler code
60760
Product ID
60760-567_50c54fee-53c2-3fa2-e063-6394a90ad727
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
ST. MARY'S MEDICAL PARK PHARMACY
Application
ANDA090469
Marketing category
ANDA
Marketing start
2022-08-25
Marketing end
2026-07-31
Substance
ONDANSETRON
Active strength
8 mg/1
Pharmacologic classes
Serotonin 3 Receptor Antagonists [MoA], Serotonin-3 Receptor Antagonist [EPC]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

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
60760-567-10Ondansetron10 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60760-567-10EA - Each60760-567d3dcf68b-80b6-4563-8219-f9d5aab15db212022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60760-567ONDANSETRON TABLET, ORALLY DISINTEGRATING [ST. MARY'S MEDICAL PARK PHARMACY]1Current NDC, Legacy NDC, 1 package rows20220914_e8823f01-ad74-0dd0-e053-2a95a90aa315.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNe8823f01-ad74-0dd0-e053-2a95a90aa3152
312087ondansetron 8 MG Disintegrating Oral TabletSCDe8823f01-ad74-0dd0-e053-2a95a90aa3152

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60760-567-106076005671010 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (60760-567-10) 2022-08-252026-07-31NoNoCurrent