Clarithromycin

Product NDC
10544-952
11-digit product format
105440952
Labeler code
10544
Product ID
10544-952_dfe82e04-8bae-40a0-b179-5e1f0edaafc9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clarithromycin
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA065178
Marketing category
ANDA
Marketing start
2015-12-02
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
10544-952-202020-01-31C16284748780-19d75b9cf-fb87-f424-e053-dadaa90a57ceCLARITHROMYCIN Tablets, USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-952-20Clarithromycin20 in 1 BOTTLE, PLASTICTABLET, COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-952-20EA - Each10544-952415eae2e-674b-49ee-9751-d99631b82f0512016-01-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-952CLARITHROMYCIN TABLET, COATED [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 1 package rows20151212_af99089d-90c6-4a36-8edb-8da0a09f1b2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNaf99089d-90c6-4a36-8edb-8da0a09f1b2a1
197517clarithromycin 500 MG Oral TabletSCDaf99089d-90c6-4a36-8edb-8da0a09f1b2a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-952-201054409522020 in 1 BOTTLE, PLASTICHistorical