Clarithromycin

Product NDC
63629-7832
11-digit product format
636297832
Labeler code
63629
Product ID
63629-7832_d12d4cdf-dcd7-4a1c-a893-43ce605d0979
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203584
Marketing category
ANDA
Marketing start
2015-12-04
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
500 mg/1
Pharmacologic classes
Cytochrome P450 3A Inhibitors [MoA], Cytochrome P450 3A4 Inhibitors [MoA], Macrolide Antimicrobial [EPC], Macrolides [CS], P-Glycoprotein Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
63629-7832-16362978320120 TABLET, FILM COATED in 1 BOTTLE (63629-7832-1) 2017-10-170000-00-00NoNoCurrent