FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
85766-006
11-digit product format
857660006
Labeler code
85766
Product ID
85766-006_4eb20508-df76-1a2a-e063-6394a90a5f40
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sportpharm 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
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 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
85766-006-00Ondansetron Hydrochloride1000 in 1 BOTTLETABLET, FILM COATED10006
85766-006-03Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED36
85766-006-05Ondansetron Hydrochloride500 in 1 BOTTLETABLET, FILM COATED5006
85766-006-06Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED66
85766-006-08Ondansetron Hydrochloride8 in 1 BOTTLETABLET, FILM COATED86
85766-006-10Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED106
85766-006-24Ondansetron Hydrochloride24 in 1 BOTTLETABLET, FILM COATED246
85766-006-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED306
85766-006-60Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED606
85766-006-90Ondansetron Hydrochloride90 in 1 BOTTLETABLET, FILM COATED906

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNb1324076-f83e-4816-9e02-6b2a689010bc6
198052ondansetron 4 MG Oral TabletSCDb1324076-f83e-4816-9e02-6b2a689010bc6
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYb1324076-f83e-4816-9e02-6b2a689010bc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85766-006-00857660006001000 TABLET, FILM COATED in 1 BOTTLE (85766-006-00) 2025-06-19NoNoCurrent
85766-006-03857660006033 TABLET, FILM COATED in 1 BOTTLE (85766-006-03) 2025-06-19NoNoCurrent
85766-006-0585766000605500 TABLET, FILM COATED in 1 BOTTLE (85766-006-05) 2025-06-19NoNoCurrent
85766-006-06857660006066 TABLET, FILM COATED in 1 BOTTLE (85766-006-06) 2025-06-19NoNoCurrent
85766-006-08857660006088 TABLET, FILM COATED in 1 BOTTLE (85766-006-08) 2026-05-04NoNoCurrent
85766-006-108576600061010 TABLET, FILM COATED in 1 BOTTLE (85766-006-10) 2025-06-19NoNoCurrent
85766-006-248576600062424 TABLET, FILM COATED in 1 BOTTLE (85766-006-24) 2025-10-01NoNoCurrent
85766-006-308576600063030 TABLET, FILM COATED in 1 BOTTLE (85766-006-30) 2025-06-19NoNoCurrent
85766-006-608576600066060 TABLET, FILM COATED in 1 BOTTLE (85766-006-60) 2025-06-19NoNoCurrent
85766-006-908576600069090 TABLET, FILM COATED in 1 BOTTLE (85766-006-90) 2025-06-19NoNoCurrent