FDA.reportPublic FDA data

Clarithromycin

Product NDC
53002-7562
11-digit product format
530027562
Labeler code
53002
Product ID
53002-7562_57e86b51-9d2d-47f2-b58d-dca66c20ccbe
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065136
Marketing category
ANDA
Marketing start
2005-08-25
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
53002-7562-12025-01-30C16284748780-12cef2736-7fb9-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
53002-7562-22025-01-30C16284748780-12cef2736-7fb9-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991
53002-7562-42025-01-30C16284748780-12cef2736-7fb9-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use CLARITHROMYCIN TABLETS safely and effectively. See full prescribing information for CLARITHROMYCIN TABLETS. CLARITHROMYCIN tablets, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-7562-1Clarithromycin10 in 1 BOTTLETABLET102
53002-7562-2Clarithromycin20 in 1 BOTTLETABLET202
53002-7562-4Clarithromycin14 in 1 BOTTLETABLET142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7562CLARITHROMYCIN TABLET [RPK PHARMACEUTICALS, INC.]2Legacy NDC, 3 package rows20220421_146e570b-c0d0-4879-9f58-8cf6287af9a6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN146e570b-c0d0-4879-9f58-8cf6287af9a62
197517clarithromycin 500 MG Oral TabletSCD146e570b-c0d0-4879-9f58-8cf6287af9a62

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-7562-15300275620110 TABLET in 1 BOTTLE (53002-7562-1) 10 tablet2021-12-310000-00-00NoNoCurrent
53002-7562-25300275620220 TABLET in 1 BOTTLE (53002-7562-2) 20 tablet2021-12-310000-00-00NoNoCurrent
53002-7562-45300275620414 TABLET in 1 BOTTLE (53002-7562-4) 14 tablet2021-12-310000-00-00NoNoCurrent