FDA.reportPublic FDA data

Clarithromycin

Product NDC
68071-5045
11-digit product format
680715045
Labeler code
68071
Product ID
68071-5045_2d53c7c3-4281-47ac-e063-6394a90a5e8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA065489
Marketing category
ANDA
Marketing start
2012-07-25
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
68071-5045-22025-02-04C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-32025-02-04C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-42025-02-04C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-82025-02-04C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-22025-01-30C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-32025-01-30C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-42025-01-30C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-82025-01-30C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-22021-02-19C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-22021-01-29C16284748780-1ba0f9c33-13b6-a910-e053-dadaa90a0b85These 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
68071-5045-2Clarithromycin20 in 1 BOTTLETABLET, FILM COATED207
68071-5045-3Clarithromycin30 in 1 BOTTLETABLET, FILM COATED307
68071-5045-4Clarithromycin14 in 1 BOTTLETABLET, FILM COATED147
68071-5045-8Clarithromycin28 in 1 BOTTLETABLET, FILM COATED287

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5045CLARITHROMYCIN TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 4 package rows20250206_9143b79c-4c79-43ac-e053-2995a90ad708.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197517clarithromycin 500 MG Oral TabletPSN9143b79c-4c79-43ac-e053-2995a90ad7087
197517clarithromycin 500 MG Oral TabletSCD9143b79c-4c79-43ac-e053-2995a90ad7087

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-5045-26807150450220 TABLET, FILM COATED in 1 BOTTLE (68071-5045-2) 2019-08-290000-00-00NoNoCurrent
68071-5045-36807150450330 TABLET, FILM COATED in 1 BOTTLE (68071-5045-3) 2019-08-29NoNoCurrent
68071-5045-46807150450414 TABLET, FILM COATED in 1 BOTTLE (68071-5045-4) 2019-08-29NoNoCurrent
68071-5045-86807150450828 TABLET, FILM COATED in 1 BOTTLE (68071-5045-8) 2019-08-290000-00-00NoNoCurrent