FDA.reportPublic FDA data

ondansetron

Product NDC
71335-0816
11-digit product format
713350816
Labeler code
71335
Product ID
71335-0816_67a58f6d-263a-44f6-a692-38aa4eebda49
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-06-25
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

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
71335-0816-0ondansetron60 in 1 BOTTLETABLET, FILM COATED605
71335-0816-1ondansetron10 in 1 BOTTLETABLET, FILM COATED105
71335-0816-2ondansetron3 in 1 BOTTLETABLET, FILM COATED35
71335-0816-3ondansetron30 in 1 BOTTLETABLET, FILM COATED305
71335-0816-4ondansetron15 in 1 BOTTLETABLET, FILM COATED155
71335-0816-5ondansetron6 in 1 BOTTLETABLET, FILM COATED65
71335-0816-6ondansetron4 in 1 BOTTLETABLET, FILM COATED45
71335-0816-7ondansetron90 in 1 BOTTLETABLET, FILM COATED905
71335-0816-8ondansetron12 in 1 BOTTLETABLET, FILM COATED125
71335-0816-9ondansetron20 in 1 BOTTLETABLET, FILM COATED205

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0816-0EA - Each71335-0816a7ef82b7-96d5-4624-90f9-a6de640fecea12018-09-05
71335-0816-1EA - Each71335-0816f4269ced-6e1e-4a2d-9457-ebe72c62beb312018-09-05
71335-0816-3EA - Each71335-0816297110ce-c649-4603-99b2-f060dfc2c91c12018-09-05
71335-0816-7EA - Each71335-0816d3b4fb6a-f05c-414a-b8e0-da547670d33412018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0816ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [BRYANT RANCH PREPACK]5Legacy NDC, 10 package rows20190913_37de0550-a6d1-46a8-a0b8-447b0dcf70ad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron HCl 8 MG Oral TabletPSN37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
198052ondansetron 4 MG Oral TabletSCD37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron 8 MG Oral TabletSCD37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY37de0550-a6d1-46a8-a0b8-447b0dcf70ad5
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY37de0550-a6d1-46a8-a0b8-447b0dcf70ad5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
71335-0816-07133508160060 in 1 BOTTLEHistorical
71335-0816-17133508160110 in 1 BOTTLEHistorical
71335-0816-2713350816023 in 1 BOTTLEHistorical
71335-0816-37133508160330 in 1 BOTTLEHistorical
71335-0816-47133508160415 in 1 BOTTLEHistorical
71335-0816-5713350816056 in 1 BOTTLEHistorical
71335-0816-6713350816064 in 1 BOTTLEHistorical
71335-0816-77133508160790 in 1 BOTTLEHistorical
71335-0816-87133508160812 in 1 BOTTLEHistorical
71335-0816-97133508160920 in 1 BOTTLEHistorical