FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
51655-016
11-digit product format
516550016
Labeler code
51655
Product ID
51655-016_4973bdb9-ab5d-58eb-e063-6294a90a883e
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
2022-08-08
Substance
ONDANSETRON HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui312086

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
51655-016-27Ondansetron Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED122
51655-016-53Ondansetron Hydrochloride10 in 1 BOTTLE, PLASTICTABLET, FILM COATED102
51655-016-54Ondansetron Hydrochloride15 in 1 BOTTLE, PLASTICTABLET, FILM COATED152
51655-016-87Ondansetron Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-016ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 4 package rows20230207_f29f8ae1-4826-d8eb-e053-2a95a90a691a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSNf29f8ae1-4826-d8eb-e053-2a95a90a691a2
312086ondansetron 8 MG Oral TabletSCDf29f8ae1-4826-d8eb-e053-2a95a90a691a2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYf29f8ae1-4826-d8eb-e053-2a95a90a691a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51655-016-275165500162712 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-016-27) 2022-09-16NoNoCurrent
51655-016-535165500165310 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-016-53) 2022-09-16NoNoCurrent
51655-016-545165500165415 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-016-54) 2022-08-08NoNoCurrent
51655-016-87516550016876 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-016-87) 2022-09-21NoNoCurrent