FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
51655-933
11-digit product format
516550933
Labeler code
51655
Product ID
51655-933_4960f7bf-1a44-0802-e063-6394a90a2855
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA078539
Marketing category
ANDA
Marketing start
2022-07-20
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 Hydrochloride
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
51655-933-04Ondansetron Hydrochloride4 in 1 BOTTLE, PLASTICTABLET, FILM COATED43
51655-933-43Ondansetron Hydrochloride3 in 1 BOTTLE, PLASTICTABLET, FILM COATED33
51655-933-53Ondansetron Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED103
51655-933-54Ondansetron Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED153
51655-933-55Ondansetron Hydrochloride5 in 1 BOTTLE, PLASTICTABLET, FILM COATED53
51655-933-87Ondansetron Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-933ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]2Current NDC, 6 package rows20230621_f76d27c5-acd4-482c-e053-6294a90a5284.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNf76d27c5-acd4-482c-e053-6294a90a52843
198052ondansetron 4 MG Oral TabletSCDf76d27c5-acd4-482c-e053-6294a90a52843
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYf76d27c5-acd4-482c-e053-6294a90a52843

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-933-04516550933044 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-933-04) 2022-10-25NoNoCurrent
51655-933-43516550933433 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-933-43) 2022-07-20NoNoCurrent
51655-933-535165509335310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-933-53) 2022-09-16NoNoCurrent
51655-933-545165509335415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-933-54) 2023-05-11NoNoCurrent
51655-933-55516550933555 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-933-55) 2023-05-09NoNoCurrent
51655-933-87516550933876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-933-87) 2022-07-20NoNoCurrent