FDA.reportPublic FDA data

Clarithromycin

Product NDC
50090-4059
11-digit product format
500904059
Labeler code
50090
Product ID
50090-4059_0e626c42-d14a-4319-a0a0-c2f5319e8078
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED, EXTENDED RELEASE
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208987
Marketing category
ANDA
Marketing start
2018-07-23
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
No
Listing certified through
2020-12-31
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
50090-4059-02023-01-30C16284748780-1f386c64a-13d9-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use CLARITHROMYCIN EXTENDED-RELEASE TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN EXTENDED-RELEASE TABLETS. CLARITHROMYCIN Extended-release tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4059-0Clarithromycin14 in 1 BOTTLETABLET, FILM COATED, EXTENDED RE141

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4059CLARITHROMYCIN TABLET, FILM COATED, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20190201_2e467e89-66c3-4690-8ebd-5ce51e1a8c38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359385clarithromycin 500 MG 24HR Extended Release Oral TabletPSN2e467e89-66c3-4690-8ebd-5ce51e1a8c381
35938524 HR clarithromycin 500 MG Extended Release Oral TabletSCD2e467e89-66c3-4690-8ebd-5ce51e1a8c381
359385clarithromycin 500 MG 24 HR Extended Release Oral TabletSY2e467e89-66c3-4690-8ebd-5ce51e1a8c381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4059-05009040590014 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50090-4059-0) 2019-01-160000-00-00NoNoCurrent