Clarithromycin

Product NDC
67296-1360
11-digit product format
672961360
Labeler code
67296
Product ID
67296-1360_d61b5c85-8596-d28f-e053-2a95a90a4896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA203584
Marketing category
ANDA
Marketing start
2015-12-04
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
67296-1360-22024-07-18C16284748780-11030e365-5745-111a-e063-dadaa90a10e25047246b-310f-5ae0-e054-00144ff8d46c
67296-1360-22024-01-30C16284748780-11030e365-5745-111a-e063-dadaa90a10e25047246b-310f-5ae0-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1360-2Clarithromycin20 in 1 BOTTLETABLET, FILM COATED204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1360CLARITHROMYCIN TABLET, FILM COATED [REDPHARM DRUG, INC.]4Legacy NDC, 1 package rows20240719_5047246b-310f-5ae0-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN5047246b-310f-5ae0-e054-00144ff8d46c4
197517clarithromycin 500 MG Oral TabletSCD5047246b-310f-5ae0-e054-00144ff8d46c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1360-26729613600220 TABLET, FILM COATED in 1 BOTTLE (67296-1360-2) 2015-12-040000-00-00NoNoCurrent