FDA.reportPublic FDA data

Ondansetron Hydrochloride

Product NDC
50268-622
11-digit product format
502680622
Labeler code
50268
Product ID
50268-622_2b4a96a8-a177-432e-e063-6294a90a8d5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvPAK
Application
ANDA078539
Marketing category
ANDA
Marketing start
2016-08-05
Substance
ONDANSETRON HYDROCHLORIDE
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 Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ONDANSETRON HYDROCHLORIDE8 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
50268-622-11Ondansetron Hydrochloride1 in 1 BLISTER PACKTABLET, FILM COATED16
50268-622-15Ondansetron Hydrochloride50 in 1 BOXTABLET, FILM COATED506

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50268-622-11EA - Each50268-62256b7e6cc-bd81-47e0-8e2e-a1ca50206c8d12016-09-02
50268-622-15EA - Each50268-622745635a4-e5af-4054-a173-c7184ce1ad3c12016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50268-622ONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [AVPAK]6Current NDC, Legacy NDC, 2 package rows20250112_e4766235-ac44-ca93-78a6-66d4ded33ada.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSNe4766235-ac44-ca93-78a6-66d4ded33ada6
312086ondansetron HCl 8 MG Oral TabletPSNe4766235-ac44-ca93-78a6-66d4ded33ada6
198052ondansetron 4 MG Oral TabletSCDe4766235-ac44-ca93-78a6-66d4ded33ada6
312086ondansetron 8 MG Oral TabletSCDe4766235-ac44-ca93-78a6-66d4ded33ada6
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSYe4766235-ac44-ca93-78a6-66d4ded33ada6
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSYe4766235-ac44-ca93-78a6-66d4ded33ada6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50268-622-11502680622111 in 1 BLISTER PACKHistorical
50268-622-155026806221550 BLISTER PACK in 1 BOX (50268-622-15) / 1 TABLET, FILM COATED in 1 BLISTER PACK (50268-622-11) 50 blister pack2016-08-050000-00-00NoNoCurrent