Clarithromycin

Product NDC
51655-668
11-digit product format
516550668
Labeler code
51655
Product ID
51655-668_494f93ea-7f13-bde7-e063-6294a90ac0ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA065136
Marketing category
ANDA
Marketing start
2023-04-03
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Clarithromycin
Listing expiration
2027-12-31

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
51655-668-20Clarithromycin20 in 1 BOTTLE, PLASTICTABLET204
51655-668-52Clarithromycin30 in 1 BOTTLE, PLASTICTABLET304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-668CLARITHROMYCIN TABLET [NORTHWIND PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20240727_f98aacb4-2f01-3e94-e053-6294a90a9aa0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNf98aacb4-2f01-3e94-e053-6294a90a9aa04
197517clarithromycin 500 MG Oral TabletSCDf98aacb4-2f01-3e94-e053-6294a90a9aa04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-668-205165506682020 TABLET in 1 BOTTLE, PLASTIC (51655-668-20) 20 tablet2023-04-03NoNoCurrent
51655-668-525165506685230 TABLET in 1 BOTTLE, PLASTIC (51655-668-52) 30 tablet2023-05-10NoNoCurrent