FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
85509-1075
11-digit product format
855091075
Labeler code
85509
Product ID
85509-1075_3f67d4c3-6148-4973-e063-6294a90aa5df
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PHOENIX RX LLC
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
85509-1075-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED103
85509-1075-2Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED203
85509-1075-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED303
85509-1075-4Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED123
85509-1075-5Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED153
85509-1075-6Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED603

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN3a79fc2b-9ea3-a808-e063-6394a90ae7943
198052ondansetron 4 MG Oral TabletSCD3a79fc2b-9ea3-a808-e063-6394a90ae7943
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY3a79fc2b-9ea3-a808-e063-6394a90ae7943

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1075-18550910750110 TABLET, FILM COATED in 1 BOTTLE (85509-1075-1) 2025-07-31NoNoCurrent
85509-1075-28550910750220 TABLET, FILM COATED in 1 BOTTLE (85509-1075-2) 2025-07-31NoNoCurrent
85509-1075-38550910750330 TABLET, FILM COATED in 1 BOTTLE (85509-1075-3) 2025-07-31NoNoCurrent
85509-1075-48550910750412 TABLET, FILM COATED in 1 BOTTLE (85509-1075-4) 2025-07-31NoNoCurrent
85509-1075-58550910750515 TABLET, FILM COATED in 1 BOTTLE (85509-1075-5) 2025-07-31NoNoCurrent
85509-1075-68550910750660 TABLET, FILM COATED in 1 BOTTLE (85509-1075-6) 2025-07-31NoNoCurrent