FDA.reportPublic FDA data

Clarithromycin

Product NDC
50090-5282
11-digit product format
500905282
Labeler code
50090
Product ID
50090-5282_81455578-b702-45f6-b99c-22968f4a4f38
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-5282-02023-02-07C16284748780-1f386c64a-3d52-0266-e053-dadaa90a7c1aThese 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
50090-5282-12023-02-07C16284748780-1f386c64a-3d52-0266-e053-dadaa90a7c1aThese 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
50090-5282-22023-02-07C16284748780-1f386c64a-3d52-0266-e053-dadaa90a7c1aThese 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
50090-5282-02023-01-30C16284748780-1f386c64a-3d52-0266-e053-dadaa90a7c1aThese 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
50090-5282-12023-01-30C16284748780-1f386c64a-3d52-0266-e053-dadaa90a7c1aThese 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
50090-5282-22023-01-30C16284748780-1f386c64a-3d52-0266-e053-dadaa90a7c1aThese 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
50090-5282-0Clarithromycin20 in 1 BOTTLETABLET208
50090-5282-1Clarithromycin30 in 1 BOTTLETABLET308
50090-5282-2Clarithromycin14 in 1 BOTTLETABLET148
50090-5282-3Clarithromycin28 in 1 BOTTLETABLET288

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5282-0EA - Each50090-5282d297645d-017e-436f-a3a3-88c344893e5112023-07-06
50090-5282-1EA - Each50090-52821a4e27d1-1fad-4aca-b89a-945a2d48c1e812023-07-06
50090-5282-2EA - Each50090-5282f14c2e97-527b-43cf-90d9-f4e8bd9697f612023-07-06
50090-5282-3EA - Each50090-5282a45b1d26-24ab-49b6-8109-887532e5ca4e12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5282CLARITHROMYCIN TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 4 package rows20231215_adba78c2-9e51-4bed-8c6a-6f977f79c40c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSNadba78c2-9e51-4bed-8c6a-6f977f79c40c8
197517clarithromycin 500 MG Oral TabletSCDadba78c2-9e51-4bed-8c6a-6f977f79c40c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5282-05009052820020 TABLET in 1 BOTTLE (50090-5282-0) 20 tablet2020-10-220000-00-00NoNoCurrent
50090-5282-15009052820130 TABLET in 1 BOTTLE (50090-5282-1) 30 tablet2020-10-220000-00-00NoNoCurrent
50090-5282-25009052820214 TABLET in 1 BOTTLE (50090-5282-2) 14 tablet2020-10-220000-00-00NoNoCurrent
50090-5282-35009052820328 TABLET in 1 BOTTLE (50090-5282-3) 28 tablet2023-12-11NoNoCurrent