FDA.reportPublic FDA data

Ondansetron

Product NDC
51655-913
11-digit product format
516550913
Labeler code
51655
Product ID
51655-913_4a8dd8e9-dd5c-efb4-e063-6294a90a89d9
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
2021-01-22
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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-913-20Ondansetron20 in 1 BAGTABLET, ORALLY DISINTEGRATING205
51655-913-53Ondansetron10 in 1 BAGTABLET, ORALLY DISINTEGRATING105
51655-913-54Ondansetron15 in 1 BAGTABLET, ORALLY DISINTEGRATING155

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-913ONDANSETRON TABLET, ORALLY DISINTEGRATING [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 3 package rows20241228_db9a0d22-9339-4319-e053-2a95a90a9592.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNdb9a0d22-9339-4319-e053-2a95a90a95925
104894ondansetron 4 MG Disintegrating Oral TabletSCDdb9a0d22-9339-4319-e053-2a95a90a95925

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-913-205165509132020 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-913-20) 2022-06-030000-00-00NoNoCurrent
51655-913-535165509135310 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-913-53) 2021-01-220000-00-00NoNoCurrent
51655-913-545165509135415 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-913-54) 2023-03-15NoNoHistorical