Clarithromycin

Product NDC
10544-522
11-digit product format
105440522
Labeler code
10544
Product ID
10544-522_f6a47a9e-897d-4982-9ee5-fd39f07e3922
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065266
Marketing category
ANDA
Marketing start
2012-10-05
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
2017-12-31
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
10544-522-142020-01-31C16284748780-19d75b9d0-807d-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP
10544-522-202020-01-31C16284748780-19d75b9d0-807d-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-522-14Clarithromycin14 in 1 BOTTLETABLET, FILM COATED141
10544-522-20Clarithromycin20 in 1 BOTTLETABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-522-20EA - Each10544-522b03e6a62-0091-41c0-ab06-a86bdeebd26d12016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-522CLARITHROMYCIN TABLET, FILM COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20160113_4452ba66-1d7a-4253-a278-b7775887e6d8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN4452ba66-1d7a-4253-a278-b7775887e6d81
197517clarithromycin 500 MG Oral TabletSCD4452ba66-1d7a-4253-a278-b7775887e6d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-522-141054405221414 in 1 BOTTLEHistorical
10544-522-201054405222020 in 1 BOTTLEHistorical