ZOFRAN

Product NDC

0078-0680

11-digit product format

000780680

Labeler code

0078

Product ID

0078-0680_aa42f7d3-3842-4b0b-8d8c-9bdf1079ae82

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

ondansetron hydrochloride

Dosage form

TABLET, ORALLY DISINTEGRATING

Route

ORAL

Labeler

Novartis Pharmaceuticals Corporation

Application

NDA020781

Marketing category

NDA

Marketing start

2017-08-23

Marketing end

2019-10-31

Substance

ONDANSETRON

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