FDA.reportPublic FDA data

Ondansetron

Product NDC
51655-809
11-digit product format
516550809
Labeler code
51655
Product ID
51655-809_4c477c71-1b8d-008e-e063-6394a90ae63b
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
2020-11-30
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
51655-809-04Ondansetron4 in 1 BAGTABLET, ORALLY DISINTEGRATING45
51655-809-53Ondansetron10 in 1 BAGTABLET, ORALLY DISINTEGRATING105
51655-809-87Ondansetron6 in 1 BAGTABLET, ORALLY DISINTEGRATING65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51655-809-87EA - Each51655-809a4b7bf60-0e40-48c5-9a6e-ef3b8bac35b112022-11-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-809ONDANSETRON TABLET, ORALLY DISINTEGRATING [NORTHWIND PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 3 package rows20241225_e07c38c0-e1c2-01de-e053-2995a90a390a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNe07c38c0-e1c2-01de-e053-2995a90a390a5
312087ondansetron 8 MG Disintegrating Oral TabletSCDe07c38c0-e1c2-01de-e053-2995a90a390a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51655-809-04516550809044 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-809-04) 2022-11-07NoNoCurrent
51655-809-535165508095310 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-809-53) 2022-05-060000-00-00NoNoCurrent
51655-809-87516550809876 TABLET, ORALLY DISINTEGRATING in 1 BAG (51655-809-87) 2020-11-300000-00-00NoNoCurrent