FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
71335-0205
11-digit product format
713350205
Labeler code
71335
Product ID
71335-0205_df4141e9-7f7f-4b5b-8299-5f6801db6db4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
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
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 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
71335-0205-0Ondansetron Hydrochloride60 in 1 BOTTLETABLET, FILM COATED609
71335-0205-1Ondansetron Hydrochloride10 in 1 BOTTLETABLET, FILM COATED109
71335-0205-2Ondansetron Hydrochloride3 in 1 BOTTLETABLET, FILM COATED39
71335-0205-3Ondansetron Hydrochloride30 in 1 BOTTLETABLET, FILM COATED309
71335-0205-4Ondansetron Hydrochloride15 in 1 BOTTLETABLET, FILM COATED159
71335-0205-5Ondansetron Hydrochloride6 in 1 BOTTLETABLET, FILM COATED69
71335-0205-6Ondansetron Hydrochloride4 in 1 BOTTLETABLET, FILM COATED49
71335-0205-7Ondansetron Hydrochloride90 in 1 BOTTLETABLET, FILM COATED909
71335-0205-8Ondansetron Hydrochloride12 in 1 BOTTLETABLET, FILM COATED129
71335-0205-9Ondansetron Hydrochloride20 in 1 BOTTLETABLET, FILM COATED209

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0205-0EA - Each71335-0205c16988fd-cc2c-4031-8860-d1ce05a0d66712018-05-09
71335-0205-1EA - Each71335-020588de777b-a0ed-43b9-91bd-8a43e98fbe4c12018-04-19
71335-0205-3EA - Each71335-020509d9e094-f628-4e11-aa53-6e7716d888e912018-04-19
71335-0205-4EA - Each71335-020583d97b0d-7bf4-41c0-8a93-11dd324db7ac12018-04-19
71335-0205-7EA - Each71335-02053e5f31d3-e888-4b58-beae-ee6e4fb1388612023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0205ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 10 package rows20240821_3aeb533a-e72c-4af8-9867-b71d2eba9a49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN3aeb533a-e72c-4af8-9867-b71d2eba9a499
198052ondansetron 4 MG Oral TabletSCD3aeb533a-e72c-4af8-9867-b71d2eba9a499
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY3aeb533a-e72c-4af8-9867-b71d2eba9a499

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-0205-07133502050060 TABLET, FILM COATED in 1 BOTTLE (71335-0205-0) 2018-04-050000-00-00NoNoCurrent
71335-0205-17133502050110 TABLET, FILM COATED in 1 BOTTLE (71335-0205-1) 2018-03-010000-00-00NoNoCurrent
71335-0205-2713350205023 TABLET, FILM COATED in 1 BOTTLE (71335-0205-2) 2021-12-270000-00-00NoNoCurrent
71335-0205-37133502050330 TABLET, FILM COATED in 1 BOTTLE (71335-0205-3) 2018-03-080000-00-00NoNoCurrent
71335-0205-47133502050415 TABLET, FILM COATED in 1 BOTTLE (71335-0205-4) 2018-02-140000-00-00NoNoCurrent
71335-0205-5713350205056 TABLET, FILM COATED in 1 BOTTLE (71335-0205-5) 2018-03-210000-00-00NoNoCurrent
71335-0205-6713350205064 TABLET, FILM COATED in 1 BOTTLE (71335-0205-6) 2021-12-270000-00-00NoNoCurrent
71335-0205-77133502050790 TABLET, FILM COATED in 1 BOTTLE (71335-0205-7) 2018-02-160000-00-00NoNoCurrent
71335-0205-87133502050812 TABLET, FILM COATED in 1 BOTTLE (71335-0205-8) 2018-03-010000-00-00NoNoCurrent
71335-0205-97133502050920 TABLET, FILM COATED in 1 BOTTLE (71335-0205-9) 2018-04-030000-00-00NoNoCurrent