FDA.reportPublic FDA data

Ondansetron

Product NDC
16714-160
11-digit product format
167140160
Labeler code
16714
Product ID
16714-160_9e8d8ea3-cbef-49ef-bcda-3ae6b9ea68d1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NorthStar Rx LLC
Application
ANDA078539
Marketing category
ANDA
Marketing start
2021-04-06
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
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
16714-160-01Ondansetron30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16714-160-01EA - Each16714-1606874ed35-eaf2-40b5-a2de-bc1e650530a612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16714-160ONDANSETRON TABLET, FILM COATED [NORTHSTAR RX LLC]3Current NDC, Legacy NDC, 1 package rows20231216_9d5e7650-95be-4b96-b29c-374f673eb7a1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN9d5e7650-95be-4b96-b29c-374f673eb7a14
312086ondansetron HCl 8 MG Oral TabletPSN9d5e7650-95be-4b96-b29c-374f673eb7a14
198052ondansetron 4 MG Oral TabletSCD9d5e7650-95be-4b96-b29c-374f673eb7a14
312086ondansetron 8 MG Oral TabletSCD9d5e7650-95be-4b96-b29c-374f673eb7a14
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY9d5e7650-95be-4b96-b29c-374f673eb7a14
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY9d5e7650-95be-4b96-b29c-374f673eb7a14
312086ondansetron HCl 8 MG Oral TabletPSN416be720-82e8-4a6d-8531-c1a29869daae3
312086ondansetron 8 MG Oral TabletSCD416be720-82e8-4a6d-8531-c1a29869daae3
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY416be720-82e8-4a6d-8531-c1a29869daae3
312086ondansetron HCl 8 MG Oral TabletPSN2553816f-161e-ac86-e063-6394a90aad6d1
312086ondansetron HCl 8 MG Oral TabletPSN2eeb3c61-4ce9-d8ed-e063-6294a90a00d31
312086ondansetron 8 MG Oral TabletSCD2553816f-161e-ac86-e063-6394a90aad6d1
312086ondansetron 8 MG Oral TabletSCD2eeb3c61-4ce9-d8ed-e063-6294a90a00d31
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2553816f-161e-ac86-e063-6394a90aad6d1
312086ondansetron 8 MG (as ondansetron HCl dihydrate 10 MG) Oral TabletSY2eeb3c61-4ce9-d8ed-e063-6294a90a00d31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
16714-160-011671401600130 TABLET, FILM COATED in 1 BOTTLE (16714-160-01) 2021-04-060000-00-00NoNoCurrent