FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
85509-1076
11-digit product format
855091076
Labeler code
85509
Product ID
85509-1076_3a76c251-0d7a-e587-e063-6394a90a308c
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
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 Hydrochloride
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
85509-1076-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED101
85509-1076-2Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED201
85509-1076-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED301
85509-1076-5Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED151
85509-1076-6Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85509-1076-1EA - Each85509-10766981ebd5-37eb-461a-b372-0c73423f282e12025-09-12
85509-1076-2EA - Each85509-1076795d65ab-bc3e-4ca4-83f4-0a9709fd9b8612025-09-12
85509-1076-3EA - Each85509-10769cb987d0-a2dc-4bc2-ba3f-d17ac3305b2212025-09-12
85509-1076-5EA - Each85509-10763a26cdb0-7734-467d-a7a9-6fddae36d82012025-09-12
85509-1076-6EA - Each85509-10769b256668-2358-4d9e-9765-9f73c8e5e54712025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN3a76bae2-04c2-ee2d-e063-6394a90ad4c81
312086ondansetron 8 MG Oral TabletSCD3a76bae2-04c2-ee2d-e063-6394a90ad4c81
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY3a76bae2-04c2-ee2d-e063-6394a90ad4c81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85509-1076-18550910760110 TABLET, FILM COATED in 1 BOTTLE (85509-1076-1) 2025-07-31NoNoHistorical
85509-1076-28550910760220 TABLET, FILM COATED in 1 BOTTLE (85509-1076-2) 2025-07-31NoNoHistorical
85509-1076-38550910760330 TABLET, FILM COATED in 1 BOTTLE (85509-1076-3) 2025-07-31NoNoHistorical
85509-1076-58550910760515 TABLET, FILM COATED in 1 BOTTLE (85509-1076-5) 2025-07-31NoNoHistorical
85509-1076-68550910760660 TABLET, FILM COATED in 1 BOTTLE (85509-1076-6) 2025-07-31NoNoHistorical