Clarithromycin

Product NDC
67296-1632
11-digit product format
672961632
Labeler code
67296
Product ID
67296-1632_b8d0796c-80c6-1386-e053-2a95a90a676f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA065489
Marketing category
ANDA
Marketing start
2019-01-01
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
No
Listing certified through
2022-12-31
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
67296-1632-22023-01-30C16284748780-1f386c649-fe79-0266-e053-dadaa90a7c1aClarithromycin 500mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1632-2Clarithromycin20 in 1 BOTTLETABLET, FILM COATED208

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1632CLARITHROMYCIN TABLET, FILM COATED [REDPHARM DRUG, INC.]8Legacy NDC, 1 package rows20210114_888d5192-8ff7-41bd-e053-2a95a90ac970.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN888d5192-8ff7-41bd-e053-2a95a90ac9708
197517clarithromycin 500 MG Oral TabletSCD888d5192-8ff7-41bd-e053-2a95a90ac9708

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67296-1632-26729616320220 TABLET, FILM COATED in 1 BOTTLE (67296-1632-2) 2019-01-010000-00-00NoNoCurrent