Clarithromycin

Product NDC

0054-0036

11-digit product format

000540036

Labeler code

0054

Product ID

0054-0036_e3198f96-a449-4919-8856-b3753079d844

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

clarithromycin

Dosage form

TABLET, COATED

Route

ORAL

Labeler

West-Ward Pharmaceuticals Corp.

Application

ANDA065178

Marketing category

ANDA

Marketing start

2004-11-22

Marketing end

2019-05-23

Substance

CLARITHROMYCIN

Active strength

250 mg/1

Pharmacologic classes

Macrolide Antimicrobial [EPC],Macrolides [CS],Cytochrome P450 3A4 Inhibitors [MoA],Cytochrome P450 3A Inhibitors [MoA],P-Glycoprotein Inhibitors [MoA]

NDC exclude flag

No

Listing certified through

0000-00-00

Current FDA listing

Historical FDA.report record