CLARITHROMYCIN

Product NDC
61919-643
11-digit product format
619190643
Labeler code
61919
Product ID
61919-643_ea4ead5d-457a-2d81-e053-2a95a90abe5b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLARITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Direct_Rx
Application
ANDA203584
Marketing category
ANDA
Marketing start
2019-08-12
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
500 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
2023-12-31
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
61919-643-102025-01-30C16284748780-12cef2736-abb6-d83d-e063-dadaa90ab31fCLARITHROMYCIN
61919-643-202025-01-30C16284748780-12cef2736-abb6-d83d-e063-dadaa90ab31fCLARITHROMYCIN
61919-643-282025-01-30C16284748780-12cef2736-a977-d83d-e063-dadaa90ab31fCLARITHROMYCIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-643-10CLARITHROMYCIN10 in 1 BOTTLETABLET, FILM COATED104
61919-643-20CLARITHROMYCIN20 in 1 BOTTLETABLET, FILM COATED204
61919-643-28CLARITHROMYCIN28 in 1 BOTTLETABLET, FILM COATED281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-643CLARITHROMYCIN TABLET, FILM COATED [DIRECT_RX]4Legacy NDC, 2 package rows20230511_8ff1fc34-9cd8-ea26-e053-2995a90a0616.zip
61919-643CLARITHROMYCIN TABLET, FILM COATED [DIRECTRX]1Legacy NDC, 1 package rows20190426_876b7723-ff80-7ccf-e053-2995a90a6fc3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN8ff1fc34-9cd8-ea26-e053-2995a90a06164
197517clarithromycin 500 MG Oral TabletSCD8ff1fc34-9cd8-ea26-e053-2995a90a06164
197517clarithromycin 500 MG Oral TabletPSN876b7723-ff80-7ccf-e053-2995a90a6fc31
197517clarithromycin 500 MG Oral TabletSCD876b7723-ff80-7ccf-e053-2995a90a6fc31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-643-106191906431010 TABLET, FILM COATED in 1 BOTTLE (61919-643-10) 2019-08-120000-00-00NoNoCurrent
61919-643-206191906432020 TABLET, FILM COATED in 1 BOTTLE (61919-643-20) 2019-11-060000-00-00NoNoCurrent
61919-643-286191906432828 TABLET, FILM COATED in 1 BOTTLE (61919-643-28) 2019-04-260000-00-00NoNoCurrent