Ondansetron Hydrochloride

Product NDC

52959-991

11-digit product format

529590991

Labeler code

52959

Product ID

52959-991_100ad196-b283-436d-9e09-40b89418afce

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ondansetron Hydrochloride

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

H.J. Harkins Company, Inc.

Application

ANDA077517

Marketing category

ANDA

Marketing start

2007-06-25

Marketing end

0000-00-00

Substance

ONDANSETRON HYDROCHLORIDE

Active strength

4 mg/1

Pharmacologic classes

Serotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]

NDC exclude flag

E

Listing certified through

2017-12-31

Current FDA listing

Historical FDA.report record