Ondansetron

Product NDC
43063-273
11-digit product format
430630273
Labeler code
43063
Product ID
43063-273_48d4d97e-6683-3407-e063-6294a90a9e72
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
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
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
43063-273-04Ondansetron4 in 1 BOTTLE, PLASTICTABLET, ORALLY DISINTEGRATING423

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-273ONDANSETRON TABLET, ORALLY DISINTEGRATING [PD-RX PHARMACEUTICALS, INC.]21Current NDC, Legacy NDC, 1 package rows20241012_d117de5f-64e5-464c-b782-de0f07e66c8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSNd117de5f-64e5-464c-b782-de0f07e66c8e23
312087ondansetron 8 MG Disintegrating Oral TabletSCDd117de5f-64e5-464c-b782-de0f07e66c8e23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-273-04430630273044 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE, PLASTIC (43063-273-04) 2011-01-270000-00-00NoNoCurrent