Ondansetron

Product NDC

51079-525

11-digit product format

510790525

Labeler code

51079

Product ID

51079-525_7d632eec-5800-6ccd-e053-2991aa0a2c07

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ondansetron

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Mylan Institutional Inc.

Application

ANDA076930

Marketing category

ANDA

Marketing start

2007-07-09

Marketing end

2019-04-30

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

0000-00-00

Current FDA listing

Historical FDA.report record