FDA.reportPublic FDA data

Ondansetron

Product NDC
51655-196
11-digit product format
516550196
Labeler code
51655
Product ID
51655-196_499ec3dc-f95c-656c-e063-6294a90a145b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA090469
Marketing category
ANDA
Marketing start
2022-07-20
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

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
51655-196-04Ondansetron4 in 1 BAGTABLET, ORALLY DISINTEGRATING45
51655-196-53Ondansetron10 in 1 BAGTABLET, ORALLY DISINTEGRATING105
51655-196-80Ondansetron8 in 1 BAGTABLET, ORALLY DISINTEGRATING85
51655-196-87Ondansetron6 in 1 BAGTABLET, ORALLY DISINTEGRATING65

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-196ONDANSETRON TABLET, ORALLY DISINTEGRATING [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, 4 package rows20240709_f2b502e2-03ed-fe5c-e053-2995a90a368e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNf2b502e2-03ed-fe5c-e053-2995a90a368e5
312087ondansetron 8 MG Disintegrating Oral TabletSCDf2b502e2-03ed-fe5c-e053-2995a90a368e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-196-04516550196044 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-04) 2023-04-27NoNoCurrent
51655-196-535165501965310 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-53) 2022-07-20NoNoCurrent
51655-196-80516550196808 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-80) 2022-07-20NoNoCurrent
51655-196-87516550196876 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-196-87) 2023-03-13NoNoCurrent