FDA.reportPublic FDA data

Ondansetron

Product NDC
71335-2635
11-digit product format
713352635
Labeler code
71335
Product ID
71335-2635_b267b802-ee97-4554-bd6a-8b8ae3c49aba
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA078152
Marketing category
ANDA
Marketing start
2007-06-27
Substance
ONDANSETRON
Active strength
8 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
ONDANSETRON8 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4AF302ESOS
Rxcui312087

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d9bd4853-037c-6968-f4d4-9bb9a0efd1eaProduct name220250722
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
32e23bc9-ce14-4555-bb6d-bcb654d7d296Product name120201015
e459f50a-1553-4aab-b6bd-1e5f0c211c49Product name120201015
909480fe-0d18-c1c1-a658-0bd9a7131822Product name520170829
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2635-0Ondansetron3 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING31
71335-2635-1Ondansetron30 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING301
71335-2635-2Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING101
71335-2635-3Ondansetron5 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING51
71335-2635-4Ondansetron4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING41
71335-2635-5Ondansetron6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING61
71335-2635-6Ondansetron14 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING141
71335-2635-7Ondansetron60 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING601
71335-2635-8Ondansetron12 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING121
71335-2635-9Ondansetron90 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN40d9cc46-aced-4866-812b-7d82933596ae1
312087ondansetron 8 MG Disintegrating Oral TabletSCD40d9cc46-aced-4866-812b-7d82933596ae1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
71335-2635-0713352635003 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-0) 2025-06-02NoNoCurrent
71335-2635-17133526350130 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-1) 2025-06-02NoNoCurrent
71335-2635-27133526350210 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-2) 2025-06-02NoNoCurrent
71335-2635-3713352635035 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-3) 2025-06-02NoNoCurrent
71335-2635-4713352635044 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-4) 2025-06-02NoNoCurrent
71335-2635-5713352635056 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-5) 2025-06-02NoNoCurrent
71335-2635-67133526350614 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-6) 2025-06-02NoNoCurrent
71335-2635-77133526350760 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-7) 2025-06-02NoNoCurrent
71335-2635-87133526350812 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-8) 2025-06-02NoNoCurrent
71335-2635-97133526350990 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK (71335-2635-9) 2025-06-02NoNoCurrent