Ondansetron

Product NDC
70518-4245
11-digit product format
705184245
Labeler code
70518
Product ID
70518-4245_4007a856-78ce-2f62-e063-6394a90a1045
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2024-12-20
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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
70518-4245-0Ondansetron30 in 1 BLISTER PACKTABLET, FILM COATED303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-4245ONDANSETRON TABLET, FILM COATED [REMEDYREPACK INC.]1Current NDC, 1 package rows20250104_416be720-82e8-4a6d-8531-c1a29869daae.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN416be720-82e8-4a6d-8531-c1a29869daae3
312086ondansetron 8 MG Oral TabletSCD416be720-82e8-4a6d-8531-c1a29869daae3
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY416be720-82e8-4a6d-8531-c1a29869daae3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70518-4245-07051842450030 TABLET, FILM COATED in 1 BLISTER PACK (70518-4245-0) 2024-12-20NoNoCurrent