FDA.reportPublic FDA data

Ondansetron

Product NDC
71335-0132
11-digit product format
713350132
Labeler code
71335
Product ID
71335-0132_aba5e1a7-a00a-4e76-b0e3-dfbe4179eec0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077851
Marketing category
ANDA
Marketing start
2007-07-27
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
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
71335-0132-0Ondansetron60 in 1 BOTTLETABLET, FILM COATED604
71335-0132-1Ondansetron10 in 1 BOTTLETABLET, FILM COATED104
71335-0132-2Ondansetron3 in 1 BOTTLETABLET, FILM COATED34
71335-0132-3Ondansetron30 in 1 BOTTLETABLET, FILM COATED304
71335-0132-4Ondansetron15 in 1 BOTTLETABLET, FILM COATED154
71335-0132-5Ondansetron6 in 1 BOTTLETABLET, FILM COATED64
71335-0132-6Ondansetron4 in 1 BOTTLETABLET, FILM COATED44
71335-0132-7Ondansetron90 in 1 BOTTLETABLET, FILM COATED904
71335-0132-8Ondansetron12 in 1 BOTTLETABLET, FILM COATED124
71335-0132-9Ondansetron20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0132ONDANSETRON TABLET, FILM COATED [BRYANT RANCH PREPACK]4Current NDC, Legacy NDC, 10 package rows20241004_f08f56de-8678-4da9-8cae-013a5c393453.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNf08f56de-8678-4da9-8cae-013a5c3934534
198052ondansetron 4 MG Oral TabletSCDf08f56de-8678-4da9-8cae-013a5c3934534
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYf08f56de-8678-4da9-8cae-013a5c3934534

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0132-07133501320060 TABLET, FILM COATED in 1 BOTTLE (71335-0132-0) 2014-04-030000-00-00NoNoCurrent
71335-0132-17133501320110 TABLET, FILM COATED in 1 BOTTLE (71335-0132-1) 2014-04-030000-00-00NoNoCurrent
71335-0132-2713350132023 TABLET, FILM COATED in 1 BOTTLE (71335-0132-2) 2014-04-030000-00-00NoNoCurrent
71335-0132-37133501320330 TABLET, FILM COATED in 1 BOTTLE (71335-0132-3) 2014-04-030000-00-00NoNoCurrent
71335-0132-47133501320415 TABLET, FILM COATED in 1 BOTTLE (71335-0132-4) 2014-04-030000-00-00NoNoCurrent
71335-0132-5713350132056 TABLET, FILM COATED in 1 BOTTLE (71335-0132-5) 2014-04-030000-00-00NoNoCurrent
71335-0132-6713350132064 TABLET, FILM COATED in 1 BOTTLE (71335-0132-6) 2014-04-030000-00-00NoNoCurrent
71335-0132-77133501320790 TABLET, FILM COATED in 1 BOTTLE (71335-0132-7) 2014-04-030000-00-00NoNoCurrent
71335-0132-87133501320812 TABLET, FILM COATED in 1 BOTTLE (71335-0132-8) 2014-04-030000-00-00NoNoCurrent
71335-0132-97133501320920 TABLET, FILM COATED in 1 BOTTLE (71335-0132-9) 2014-04-030000-00-00NoNoCurrent