Clarithromycin

Product NDC
50090-0927
11-digit product format
500900927
Labeler code
50090
Product ID
50090-0927_00ba1494-ad88-49d5-bb9f-ce0ab6193853
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065489
Marketing category
ANDA
Marketing start
2012-07-25
Substance
CLARITHROMYCIN
Active strength
250 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 formatDescriptionMarketing startSampleExclude flagStatus
50090-0927-05009009270020 TABLET, FILM COATED in 1 BOTTLE (50090-0927-0) 2014-11-28NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ClarithromycinA-S Medication Solutions2023-07-31Human Prescription Drug Label4