FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
70518-3511
11-digit product format
705183511
Labeler code
70518
Product ID
70518-3511_4f1f81e0-a120-5902-e063-6294a90ad278
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA078539
Marketing category
ANDA
Marketing start
2022-09-06
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
70518-3511-0Ondansetron Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED308
70518-3511-1Ondansetron Hydrochloride30 in 1 BLISTER PACKTABLET, FILM COATED308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3511ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [REMEDYREPACK INC.]5Current NDC, Legacy NDC, 2 package rows20240711_5cc67d95-6629-4451-9e34-2f7a60482be5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN5cc67d95-6629-4451-9e34-2f7a60482be58
312086ondansetron 8 MG Oral TabletSCD5cc67d95-6629-4451-9e34-2f7a60482be58
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY5cc67d95-6629-4451-9e34-2f7a60482be58

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-3511-07051835110030 TABLET, FILM COATED in 1 BLISTER PACK (70518-3511-0) 2022-09-060000-00-00NoNoCurrent
70518-3511-17051835110130 TABLET, FILM COATED in 1 BLISTER PACK (70518-3511-1) 2025-07-02NoNoHistorical