FDA.reportPublic FDA data

Ondansetron

Product NDC
71335-2972
11-digit product format
713352972
Labeler code
71335
Product ID
71335-2972_fdab7199-a313-47a6-9a5a-fc1b27a402d2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209389
Marketing category
ANDA
Marketing start
2025-06-19
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Ondansetron
Listing expiration
2027-12-31

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
71335-2972-1Ondansetron20 in 1 BOTTLETABLET, ORALLY DISINTEGRATING202
71335-2972-2Ondansetron60 in 1 BOTTLETABLET, ORALLY DISINTEGRATING602
71335-2972-3Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING302
71335-2972-4Ondansetron10 in 1 BOTTLETABLET, ORALLY DISINTEGRATING102
71335-2972-5Ondansetron15 in 1 BOTTLETABLET, ORALLY DISINTEGRATING152
71335-2972-6Ondansetron6 in 1 BOTTLETABLET, ORALLY DISINTEGRATING62
71335-2972-7Ondansetron3 in 1 BOTTLETABLET, ORALLY DISINTEGRATING32
71335-2972-8Ondansetron5 in 1 BOTTLETABLET, ORALLY DISINTEGRATING52

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2972-1EA - Each71335-2972c71ac09b-63f5-457b-bb09-10d490afadb512026-03-17
71335-2972-2EA - Each71335-29727427d756-2d62-41ee-bcb7-cd82e98e5a0f12026-03-17
71335-2972-3EA - Each71335-297272802fca-604e-4cac-8af8-bae1b48bbb9a12026-03-17
71335-2972-4EA - Each71335-297242b936f0-e994-47a1-afab-1c807c86e57712026-03-17
71335-2972-5EA - Each71335-2972c90fa81c-bafc-4584-b216-89b2b6c6105d12026-03-17
71335-2972-6EA - Each71335-29721ca1f6e8-6b70-4377-9cd6-cc3f3418547512026-03-17
71335-2972-7EA - Each71335-297205afd3bb-c56d-463b-a795-7bbac5ed984f12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSNc83821ad-822e-47dc-8108-612312cf3a162
104894ondansetron 4 MG Disintegrating Oral TabletSCDc83821ad-822e-47dc-8108-612312cf3a162

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2972-17133529720120 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-1) 2025-10-29NoNoHistorical
71335-2972-27133529720260 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-2) 2025-10-29NoNoHistorical
71335-2972-37133529720330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-3) 2025-10-29NoNoHistorical
71335-2972-47133529720410 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-4) 2025-10-29NoNoHistorical
71335-2972-57133529720515 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-5) 2025-10-29NoNoHistorical
71335-2972-6713352972066 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-6) 2025-10-29NoNoHistorical
71335-2972-7713352972073 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-7) 2025-10-29NoNoHistorical
71335-2972-8713352972085 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (71335-2972-8) 2025-10-29NoNoHistorical