Ondansetron

Product NDC
0781-1679
11-digit product format
007811679
Labeler code
0781
Product ID
0781-1679_aeb4f81b-0b25-4aac-9d7b-f135d2d18fee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Ondansetron
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Sandoz Inc
Application
ANDA077517
Marketing category
ANDA
Marketing start
2007-06-25
Marketing end
2019-11-30
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
0000-00-00
Current FDA listing
Historical FDA.report record

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-1679-31EA - Each0781-167938544584-5f4f-45c5-92ca-7ba29a4ff49412012-07-24
0781-1679-33EA - Each0781-1679ebf888a4-d991-4315-89fd-a4906f7264ab12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ONDANSETRON HYDROCHLORIDEACTIVE INGREDIENTNMH84OZK2BONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]5
ONDANSETRONACTIVE MOIETY4AF302ESOSONDANSETRON HYDROCHLORIDE TABLET, FILM COATED [H.J. HARKINS COMPANY, INC.]5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198052ondansetron HCl 4 MG Oral TabletPSN93f6d82b-0594-4b48-9711-201d79a033155
198052ondansetron 4 MG Oral TabletSCD93f6d82b-0594-4b48-9711-201d79a033155
198052ondansetron 4 MG (as ondansetron HCl dihydrate 5 MG) Oral TabletSY93f6d82b-0594-4b48-9711-201d79a033155