ONDANSETRON

Product NDC
51662-1678
11-digit product format
516621678
Labeler code
51662
Product ID
51662-1678_4dcd1e4c-6a9d-7ac6-e063-6394a90a39bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ONDANSETRON
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HF Acquisition Co LLC, DBA HealthFirst
Application
ANDA076183
Marketing category
ANDA
Marketing start
2006-12-26
Substance
ONDANSETRON HYDROCHLORIDE
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
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052

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
51662-1678-1ONDANSETRON30 in 1 BOTTLETABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf1
198052ondansetron 4 MG Oral TabletSCD4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf1
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY4dcd1e4c-6a9c-7ac6-e063-6394a90a39bf1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51662-1678-15166216780130 TABLET, FILM COATED in 1 BOTTLE (51662-1678-1) 2006-12-26NoNoCurrent