FDA.reportPublic FDA data

Ondansetron

Product NDC
83980-013
11-digit product format
839800013
Labeler code
83980
Product ID
83980-013_3582cf26-d9a0-4b93-93a1-d1824e55fc19
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, ORALLY DISINTEGRATING
Route
ORAL
Labeler
Ipca Laboratories Limited
Application
ANDA209389
Marketing category
ANDA
Marketing start
2025-06-19
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
Rxcui104894, 312087

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
83980-013-01Ondansetron100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1002
83980-013-10Ondansetron1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10002
83980-013-13Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING302
83980-013-83Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102
83980-013-83Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING32

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83980-013-13EA - Each83980-0132a650dbb-5523-4f78-8095-b2f048e69fd812025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312087ondansetron 8 MG Disintegrating Oral TabletPSN40258e4b-5e67-46c0-8ef0-3e8bfe36ba113
312087ondansetron 8 MG Disintegrating Oral TabletSCD40258e4b-5e67-46c0-8ef0-3e8bfe36ba113
104894ondansetron 4 MG Disintegrating Oral TabletPSN8e24f935-87fe-4b6a-b265-60b1039f38d52
312087ondansetron 8 MG Disintegrating Oral TabletPSN8e24f935-87fe-4b6a-b265-60b1039f38d52
104894ondansetron 4 MG Disintegrating Oral TabletSCD8e24f935-87fe-4b6a-b265-60b1039f38d52
312087ondansetron 8 MG Disintegrating Oral TabletSCD8e24f935-87fe-4b6a-b265-60b1039f38d52
312087ondansetron 8 MG Disintegrating Oral TabletPSN7949c245-b79f-4eaf-a75f-9a17bd7bd3071
312087ondansetron 8 MG Disintegrating Oral TabletSCD7949c245-b79f-4eaf-a75f-9a17bd7bd3071

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83980-013-0183980001301100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-01) 2025-06-19NoNoCurrent
83980-013-10839800013101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-10) 2025-06-19NoNoCurrent
83980-013-138398000131330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-013-13) 2025-06-19NoNoCurrent
83980-013-83839800013833 BLISTER PACK in 1 CARTON (83980-013-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2025-06-19NoNoCurrent