FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
50090-6342
11-digit product format
500906342
Labeler code
50090
Product ID
50090-6342_00a96556-045b-4814-b82d-9513aaa7faa0
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

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
50090-6342-0Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101
50090-6342-1Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED61
50090-6342-2Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
50090-6342-4Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED31
50090-6342-5Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-6342-0EA - Each50090-6342259e9245-fdc9-4204-bdba-8ad3e527be7a12023-02-06
50090-6342-1EA - Each50090-6342ff5da37c-6590-475f-bde8-cc2a8d26ffe512023-02-06
50090-6342-2EA - Each50090-6342b346031a-fd7f-4f4e-8cf5-fe704c67c6e912023-02-06
50090-6342-4EA - Each50090-634208f4469d-aa4c-44c0-92aa-b45a969f158512023-02-06
50090-6342-5EA - Each50090-6342754db471-6db8-42db-a0b7-bd654f48224012023-02-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6342ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]1Current NDC, 5 package rows20230124_f8f371c7-09f8-426c-ae22-753cd5626da3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNf8f371c7-09f8-426c-ae22-753cd5626da31
198052ondansetron 4 MG Oral TabletSCDf8f371c7-09f8-426c-ae22-753cd5626da31
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYf8f371c7-09f8-426c-ae22-753cd5626da31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-6342-05009063420010 TABLET, FILM COATED in 1 BOTTLE (50090-6342-0) 2023-01-23NoNoCurrent
50090-6342-1500906342016 TABLET, FILM COATED in 1 BOTTLE (50090-6342-1) 2023-01-23NoNoCurrent
50090-6342-25009063420220 TABLET, FILM COATED in 1 BOTTLE (50090-6342-2) 2023-01-23NoNoCurrent
50090-6342-4500906342043 TABLET, FILM COATED in 1 BOTTLE (50090-6342-4) 2023-01-23NoNoCurrent
50090-6342-55009063420512 TABLET, FILM COATED in 1 BOTTLE (50090-6342-5) 2023-01-23NoNoCurrent