FDA.reportPublic FDA data

Ondansetron

Product NDC
68788-7565
11-digit product format
687887565
Labeler code
68788
Product ID
68788-7565_89fef2fe-3afe-49ab-a5fe-b6cb7af4fe9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA090469
Marketing category
ANDA
Marketing start
2019-12-27
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
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
68788-7565-1Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING107
68788-7565-3Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7565-1EA - Each68788-756553a548f4-8f43-42e7-85c5-df2f5edf472012020-08-06
68788-7565-3EA - Each68788-7565205f0f0c-658d-4603-828c-590c08ded73812020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7565ONDANSETRON TABLET, ORALLY DISINTEGRATING [PREFERRED PHARMACEUTICALS, INC.]6Current NDC, Legacy NDC, 2 package rows20240726_70b48280-ef74-472b-abc3-128962bfcb05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN70b48280-ef74-472b-abc3-128962bfcb057
312087ondansetron 8 MG Disintegrating Oral TabletSCD70b48280-ef74-472b-abc3-128962bfcb057

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7565-16878875650110 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68788-7565-1) 2019-12-270000-00-00NoNoCurrent
68788-7565-36878875650330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (68788-7565-3) 2019-12-270000-00-00NoNoCurrent