Ondansetron

Product NDC

35356-853

11-digit product format

353560853

Labeler code

35356

Product ID

35356-853_92a82257-b1a4-4250-9997-59ff814a4d3f

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

Ondansetron

Dosage form

TABLET, FILM COATED

Route

ORAL

Labeler

Lake Erie Medical DBA Quality Care Products LLC

Application

ANDA077851

Marketing category

ANDA

Marketing start

2007-07-27

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

No

Listing certified through

2020-12-31

Current FDA listing

Historical FDA.report record