FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
50090-3178
11-digit product format
500903178
Labeler code
50090
Product ID
50090-3178_f74fee7b-ae98-4fbb-84fb-23cd573e3936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA078539
Marketing category
ANDA
Marketing start
2007-07-31
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

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
50090-3178-0Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED1011
50090-3178-1Ondansetron Hydrochloride6 in 1 BOTTLE, PLASTICTABLET, FILM COATED611
50090-3178-2Ondansetron Hydrochloride20 in 1 BOTTLE, PLASTICTABLET, FILM COATED2011
50090-3178-4Ondansetron Hydrochloride3 in 1 BOTTLE, PLASTICTABLET, FILM COATED311
50090-3178-5Ondansetron Hydrochloride12 in 1 BOTTLE, PLASTICTABLET, FILM COATED1211

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-3178-0EA - Each50090-31784b0c305a-8f26-4b4b-94ef-01894cb9023f12018-12-13
50090-3178-1EA - Each50090-31787c618076-9a95-4794-ae4d-5fa428193eb112019-05-02
50090-3178-2EA - Each50090-31781ef609e3-9d04-4e81-bdc6-28a42a27e12212019-05-02
50090-3178-4EA - Each50090-3178b9c5bb44-4f53-4cae-82a1-061e1d3d7af812019-05-02
50090-3178-5EA - Each50090-3178b2bc7722-1e79-4cc9-a779-6cf1ec64f1b612019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3178ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]11Current NDC, Legacy NDC, 5 package rows20231027_674ea285-8f84-4603-9655-82200c523fe5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron HCl 8 MG Oral TabletPSN674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron 4 MG Oral TabletSCD674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron 8 MG Oral TabletSCD674ea285-8f84-4603-9655-82200c523fe511
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY674ea285-8f84-4603-9655-82200c523fe511
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY674ea285-8f84-4603-9655-82200c523fe511

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-3178-05009031780010 TABLET, FILM COATED in 1 BOTTLE (50090-3178-0) 2017-11-060000-00-00NoNoCurrent
50090-3178-1500903178016 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-1) 2014-11-280000-00-00NoNoCurrent
50090-3178-25009031780220 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-2) 2014-11-280000-00-00NoNoCurrent
50090-3178-4500903178043 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-4) 2014-11-280000-00-00NoNoCurrent
50090-3178-55009031780512 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (50090-3178-5) 2014-11-280000-00-00NoNoCurrent