FDA.reportPublic FDA data

Ondansetron

Product NDC
71335-1314
11-digit product format
713351314
Labeler code
71335
Product ID
71335-1314_b16468ac-e482-41d2-ac22-966ad7807bcf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
Substance
ONDANSETRON
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
ONDANSETRON4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui104894

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
71335-1314-0Ondansetron90 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING908
71335-1314-1Ondansetron30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING308
71335-1314-2Ondansetron20 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING208
71335-1314-3Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING108
71335-1314-4Ondansetron6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING68
71335-1314-5Ondansetron60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING608
71335-1314-6Ondansetron9 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING98
71335-1314-7Ondansetron5 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING58
71335-1314-8Ondansetron15 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING158
71335-1314-9Ondansetron3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING38

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1314-1EA - Each71335-131401dbb7a0-06f2-472f-a822-97be1770b30f12019-12-10
71335-1314-2EA - Each71335-1314cd15b03d-4295-4544-8aae-6343d950e37712021-04-08
71335-1314-3EA - Each71335-1314aa3010a5-9164-4dda-90d3-6dfb592048e812020-04-20
71335-1314-4EA - Each71335-1314013910b0-bb37-4ff4-ba1b-b79bf12833e112025-08-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1314ONDANSETRON TABLET, ORALLY DISINTEGRATING [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 10 package rows20240823_ee668456-a214-4452-ab9d-ec00eaa41d79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNee668456-a214-4452-ab9d-ec00eaa41d798
104894ondansetron 4 MG Disintegrating Oral TabletSCDee668456-a214-4452-ab9d-ec00eaa41d798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1314-07133513140090 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-0) 2019-09-090000-00-00NoNoCurrent
71335-1314-17133513140130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-1) 2019-09-200000-00-00NoNoCurrent
71335-1314-27133513140220 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-2) 2020-05-140000-00-00NoNoCurrent
71335-1314-37133513140310 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-3) 2019-09-110000-00-00NoNoCurrent
71335-1314-4713351314046 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-4) 2019-09-160000-00-00NoNoCurrent
71335-1314-57133513140560 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-5) 2019-11-260000-00-00NoNoCurrent
71335-1314-6713351314069 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-6) 2024-04-030000-00-00NoNoCurrent
71335-1314-7713351314075 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-7) 2019-10-180000-00-00NoNoCurrent
71335-1314-87133513140815 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-8) 2019-10-140000-00-00NoNoCurrent
71335-1314-9713351314093 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-1314-9) 2020-11-050000-00-00NoNoCurrent