FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
71205-744
11-digit product format
712050744
Labeler code
71205
Product ID
71205-744_33d02d85-fb3b-48c1-85db-4be993bfcc96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
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
71205-744-10Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED102
71205-744-12Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED122
71205-744-15Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED152
71205-744-20Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED202
71205-744-30Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED302
71205-744-60Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED602
71205-744-90Ondansetron Hydrochloride90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-744-10EA - Each71205-744cb3eba06-f33d-4ad9-863e-800a0ca54e1c12023-12-05
71205-744-12EA - Each71205-74409937177-c388-49e5-b182-0a594fc26eb012023-08-08
71205-744-30EA - Each71205-7443eae6337-49e5-4b98-9aa3-e4a0303ef9b112023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-744ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, 7 package rows20230617_65f01335-452e-42c6-a59b-4eb03badc55a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312086ondansetron HCl 8 MG Oral TabletPSN65f01335-452e-42c6-a59b-4eb03badc55a2
312086ondansetron 8 MG Oral TabletSCD65f01335-452e-42c6-a59b-4eb03badc55a2
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY65f01335-452e-42c6-a59b-4eb03badc55a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71205-744-107120507441010 TABLET, FILM COATED in 1 BOTTLE (71205-744-10) 2023-01-16NoNoHistorical
71205-744-127120507441212 TABLET, FILM COATED in 1 BOTTLE (71205-744-12) 2023-06-13NoNoHistorical
71205-744-157120507441515 TABLET, FILM COATED in 1 BOTTLE (71205-744-15) 2023-01-16NoNoHistorical
71205-744-207120507442020 TABLET, FILM COATED in 1 BOTTLE (71205-744-20) 2023-01-16NoNoHistorical
71205-744-307120507443030 TABLET, FILM COATED in 1 BOTTLE (71205-744-30) 2023-01-16NoNoHistorical
71205-744-607120507446060 TABLET, FILM COATED in 1 BOTTLE (71205-744-60) 2023-01-16NoNoHistorical
71205-744-907120507449090 TABLET, FILM COATED in 1 BOTTLE (71205-744-90) 2023-01-16NoNoHistorical