Clarithromycin

Product NDC
76420-051
11-digit product format
764200051
Labeler code
76420
Product ID
76420-051_b21449e8-c203-520d-e053-2995a90ad298
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, Inc.
Application
ANDA065136
Marketing category
ANDA
Marketing start
2005-08-25
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clarithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLARITHROMYCIN500 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH1250JIK0A
Rxcui197517

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-051-14Clarithromycin14 in 1 BOTTLETABLET141
76420-051-20Clarithromycin20 in 1 BOTTLETABLET201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-051CLARITHROMYCIN TABLET [ASCLEMED USA, INC.]1Current NDC, Legacy NDC, 2 package rows20201021_a12e4d38-e0f8-4467-a26c-bb25a342aa92.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNa12e4d38-e0f8-4467-a26c-bb25a342aa921
197517clarithromycin 500 MG Oral TabletSCDa12e4d38-e0f8-4467-a26c-bb25a342aa921

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-051-147642000511414 TABLET in 1 BOTTLE (76420-051-14) 14 tablet2020-10-200000-00-00NoNoCurrent
76420-051-207642000512020 TABLET in 1 BOTTLE (76420-051-20) 20 tablet2020-10-200000-00-00NoNoCurrent