Clarithromycin

Product NDC
70934-905
11-digit product format
709340905
Labeler code
70934
Product ID
70934-905_d5e297d4-b10b-9aa9-e053-2a95a90a6709
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA065136
Marketing category
ANDA
Marketing start
2021-09-28
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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-905-207093409052020 TABLET in 1 BOTTLE, PLASTIC (70934-905-20) 20 tablet2022-01-180000-00-00NoNoCurrent
70934-905-307093409053030 TABLET in 1 BOTTLE, PLASTIC (70934-905-30) 30 tablet2021-09-280000-00-00NoNoCurrent