FDA.reportPublic FDA data

Ondansetron

Product NDC
83980-012
11-digit product format
839800012
Labeler code
83980
Product ID
83980-012_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
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, 312087

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
83980-012-01Ondansetron100 in 1 BOTTLETABLET, ORALLY DISINTEGRATING1002
83980-012-10Ondansetron1000 in 1 BOTTLETABLET, ORALLY DISINTEGRATING10002
83980-012-13Ondansetron30 in 1 BOTTLETABLET, ORALLY DISINTEGRATING302
83980-012-83Ondansetron3 in 1 CARTONTABLET, ORALLY DISINTEGRATING32
83980-012-83Ondansetron10 in 1 BLISTER PACKTABLET, ORALLY DISINTEGRATING102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83980-012-13EA - Each83980-012539f9920-0dc9-4eb2-a060-f2daac3b4d6d12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
104894ondansetron 4 MG Disintegrating Oral TabletPSN8e24f935-87fe-4b6a-b265-60b1039f38d52
104894ondansetron 4 MG Disintegrating Oral TabletPSNc83821ad-822e-47dc-8108-612312cf3a162
312087ondansetron 8 MG Disintegrating Oral TabletPSN8e24f935-87fe-4b6a-b265-60b1039f38d52
104894ondansetron 4 MG Disintegrating Oral TabletSCD8e24f935-87fe-4b6a-b265-60b1039f38d52
104894ondansetron 4 MG Disintegrating Oral TabletSCDc83821ad-822e-47dc-8108-612312cf3a162
312087ondansetron 8 MG Disintegrating Oral TabletSCD8e24f935-87fe-4b6a-b265-60b1039f38d52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83980-012-0183980001201100 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-01) 2025-06-19NoNoCurrent
83980-012-10839800012101000 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-10) 2025-06-19NoNoCurrent
83980-012-138398000121330 TABLET, ORALLY DISINTEGRATING in 1 BOTTLE (83980-012-13) 2025-06-19NoNoCurrent
83980-012-83839800012833 BLISTER PACK in 1 CARTON (83980-012-83) / 10 TABLET, ORALLY DISINTEGRATING in 1 BLISTER PACK3 blister pack2025-06-19NoNoCurrent