FDA.reportPublic FDA data

Ondansetron

Product NDC
85766-038
11-digit product format
857660038
Labeler code
85766
Product ID
85766-038_4a2b4364-9eaf-2994-e063-6394a90aa9bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Sportpharm LLC
Application
ANDA090469
Marketing category
ANDA
Marketing start
2010-04-12
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
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
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
85766-038-04Ondansetron4 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING43
85766-038-04Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING13
85766-038-06Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING13
85766-038-06Ondansetron6 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING63
85766-038-10Ondansetron1 in 1 CARTONTABLET, ORALLY DISINTEGRATING13
85766-038-10Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
85766-038-20Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
85766-038-20Ondansetron2 in 1 CARTONTABLET, ORALLY DISINTEGRATING23
85766-038-24Ondansetron24 in 1 BOTTLETABLET, ORALLY DISINTEGRATING243
85766-038-30Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING103
85766-038-30Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING33

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN3c4cda2f-13d9-42c5-b449-77deb06c8de53
312087ondansetron 8 MG Disintegrating Oral TabletSCD3c4cda2f-13d9-42c5-b449-77deb06c8de53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85766-038-04857660038041 BLISTER PACK in 1 CARTON (85766-038-04) / 4 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2025-08-07NoNoHistorical
85766-038-06857660038061 BLISTER PACK in 1 CARTON (85766-038-06) / 6 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2025-08-07NoNoHistorical
85766-038-10857660038101 BLISTER PACK in 1 CARTON (85766-038-10) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK1 blister pack2025-08-07NoNoHistorical
85766-038-20857660038202 BLISTER PACK in 1 CARTON (85766-038-20) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK2 blister pack2025-08-07NoNoHistorical
85766-038-248576600382424 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (85766-038-24) 2025-10-03NoNoHistorical
85766-038-30857660038303 BLISTER PACK in 1 CARTON (85766-038-30) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2025-08-07NoNoHistorical