FDA.reportPublic FDA data

ondansetron

Product NDC
0904-6551
11-digit product format
009046551
Labeler code
0904
Product ID
0904-6551_50aa5f42-2197-43a5-836a-4e0c96209a8b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ondansetron hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Major Pharmaceuticals
Application
ANDA076183
Marketing category
ANDA
Marketing start
2006-12-26
Substance
ONDANSETRON HYDROCHLORIDE
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
ONDANSETRON HYDROCHLORIDE4 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiNMH84OZK2B
Rxcui198052, 312086

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
0904-6551-61ondansetron100 in 1 CARTONTABLET, FILM COATED10010
0904-6551-61ondansetron1 in 1 BLISTER PACKTABLET, FILM COATED110

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6551-61EA - Each0904-65512f59582b-86c4-4939-a16c-43f897ea739a12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0904-6551ONDANSETRON (ONDANSETRON HYDROCHLORIDE) TABLET, FILM COATED [MAJOR PHARMACEUTICALS]8Current NDC, Legacy NDC, 2 package rows20250416_a29b5c18-9884-4c88-8827-65d9ad5f69f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNa29b5c18-9884-4c88-8827-65d9ad5f69f610
312086ondansetron HCl 8 MG Oral TabletPSNa29b5c18-9884-4c88-8827-65d9ad5f69f610
198052ondansetron 4 MG Oral TabletSCDa29b5c18-9884-4c88-8827-65d9ad5f69f610
312086ondansetron 8 MG Oral TabletSCDa29b5c18-9884-4c88-8827-65d9ad5f69f610
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYa29b5c18-9884-4c88-8827-65d9ad5f69f610
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYa29b5c18-9884-4c88-8827-65d9ad5f69f610
198052ondansetron HCl 4 MG Oral TabletPSNcb02f2d7-31a9-4f12-880e-7ce7d85440d46
312086ondansetron HCl 8 MG Oral TabletPSNcb02f2d7-31a9-4f12-880e-7ce7d85440d46
198052ondansetron 4 MG Oral TabletSCDcb02f2d7-31a9-4f12-880e-7ce7d85440d46
312086ondansetron 8 MG Oral TabletSCDcb02f2d7-31a9-4f12-880e-7ce7d85440d46
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYcb02f2d7-31a9-4f12-880e-7ce7d85440d46
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYcb02f2d7-31a9-4f12-880e-7ce7d85440d46
198052ondansetron HCl 4 MG Oral TabletPSNcdb2c4b4-a20a-3f8f-e053-2a95a90aaf722
198052ondansetron 4 MG Oral TabletSCDcdb2c4b4-a20a-3f8f-e053-2a95a90aaf722
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYcdb2c4b4-a20a-3f8f-e053-2a95a90aaf722

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0904-6551-6100904655161100 BLISTER PACK in 1 CARTON (0904-6551-61) / 1 TABLET, FILM COATED in 1 BLISTER PACK100 blister pack2006-12-260000-00-00NoNoCurrent