clarithromycin

Product NDC

42291-263

11-digit product format

422910263

Labeler code

42291

Product ID

42291-263_63262a47-d42f-ff7f-e053-2a91aa0af278

Type

HUMAN PRESCRIPTION DRUG

Nonproprietary name

clarithromycin

Dosage form

TABLET, FILM COATED, EXTENDED RELEASE

Route

ORAL

Labeler

AvKARE, Inc.

Application

ANDA065145

Marketing category

ANDA

Marketing start

2017-04-20

Marketing end

0000-00-00

Substance

CLARITHROMYCIN

Active strength

500 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

2020-12-31

Current FDA listing

Historical FDA.report record