FDA.reportPublic FDA data

Clarithromycin

Product NDC
50090-2515
11-digit product format
500902515
Labeler code
50090
Product ID
50090-2515_b03a02b2-956e-4b18-bc2b-f0fc55f189e1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203584
Marketing category
ANDA
Marketing start
2015-12-04
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
50090-2515-02023-01-30C16284748780-1f386c64a-2bfa-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 USP, for oral use Initial U.S. Approval: 1991
50090-2515-12023-01-30C16284748780-1f386c64a-2bfa-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 USP, for oral use Initial U.S. Approval: 1991
50090-2515-22023-01-30C16284748780-1f386c64a-2bfa-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 USP, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2515-0Clarithromycin20 in 1 BOTTLETABLET, FILM COATED209
50090-2515-1Clarithromycin30 in 1 BOTTLETABLET, FILM COATED309
50090-2515-2Clarithromycin14 in 1 BOTTLETABLET, FILM COATED149

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2515-0EA - Each50090-25158d097e3c-39c9-40b2-ad32-19036d12645a12019-03-12
50090-2515-1EA - Each50090-251549f42f08-3912-47ee-8fd9-45e7a89062fe12019-03-12
50090-2515-2EA - Each50090-2515f9789529-60df-4e75-8297-5f86d514f4b512019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2515CLARITHROMYCIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]9Legacy NDC, 3 package rows20210804_2a7bb675-0ef5-44c0-a8c2-72aa3334f29d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSN2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9
197517clarithromycin 500 MG Oral TabletPSN2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9
197516clarithromycin 250 MG Oral TabletSCD2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9
197517clarithromycin 500 MG Oral TabletSCD2a7bb675-0ef5-44c0-a8c2-72aa3334f29d9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-2515-05009025150020 TABLET, FILM COATED in 1 BOTTLE (50090-2515-0) 2016-12-010000-00-00NoNoCurrent
50090-2515-15009025150130 TABLET, FILM COATED in 1 BOTTLE (50090-2515-1) 2016-10-210000-00-00NoNoCurrent
50090-2515-25009025150214 TABLET, FILM COATED in 1 BOTTLE (50090-2515-2) 2016-10-140000-00-00NoNoCurrent