clarithromycin

Product NDC
55695-018
11-digit product format
556950018
Labeler code
55695
Product ID
55695-018_2b5aef5f-d96f-55e0-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clarithromycin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
Department of State Health Services, Pharmacy Branch
Application
ANDA065145
Marketing category
ANDA
Marketing start
2008-01-01
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
E
Listing certified through
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2bb254ff-3d7f-4bdb-abf9-476506008c55Product name120230117
e3d1ac4d-bee8-bcec-c4e6-12004dcb6ab2Product name720221114
8690a824-4bf8-4d1e-b118-2d6dda86bc04Product name220161206

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55695-018-002020-01-31C16284748780-19d75b9cf-db92-f424-e053-dadaa90a57ceCLARITHROMYCIN EXTENDED-RELEASE TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55695-018-00clarithromycin60 in 1 BOTTLE, PLASTICTABLET, FILM COATED, EXTENDED RE601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55695-018CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH]1Legacy NDC, 1 package rows20160311_2b5aef5f-d96e-55e0-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359385clarithromycin 500 MG 24HR Extended Release Oral TabletPSN2b5aef5f-d96e-55e0-e054-00144ff8d46c1
35938524 HR clarithromycin 500 MG Extended Release Oral TabletSCD2b5aef5f-d96e-55e0-e054-00144ff8d46c1
359385clarithromycin 500 MG 24 HR Extended Release Oral TabletSY2b5aef5f-d96e-55e0-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
55695-018-005569500180060 in 1 BOTTLE, PLASTICHistorical