Clarithromycin

Product NDC
67046-1515
11-digit product format
670461515
Labeler code
67046
Product ID
67046-1515_2d6d01fe-a7b9-cbff-e063-6294a90a6bca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Coupler LLC
Application
ANDA065136
Marketing category
ANDA
Marketing start
2025-02-05
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
H1250JIK0ACLARITHROMYCIN81103-11-9CLARITHROMYCIN

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
67046-1515-36704615150330 TABLET in 1 BLISTER PACK (67046-1515-3) 30 tablet2025-02-05NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ClarithromycinCoupler LLC2025-02-05HUMAN PRESCRIPTION DRUG LABEL1