Clarithromycin

Product NDC
33261-631
11-digit product format
332610631
Labeler code
33261
Product ID
33261-631_c32a755e-ce62-4ae6-a581-e1f2f26e65ed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clarithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA065266
Marketing category
ANDA
Marketing start
2006-05-31
Marketing end
0000-00-00
Substance
CLARITHROMYCIN
Active strength
250 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
2019-12-31
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
33261-631-202020-01-31C16284748780-19d75b9d1-24c0-f424-e053-dadaa90a57ceCLARITHROMYCIN TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-631-20Clarithromycin20 in 1 BOTTLE, PLASTICTABLET, FILM COATED201

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-631-20EA - Each33261-631929f955b-30d0-4f96-bfee-3a67cd5d590c12015-10-02

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-631CLARITHROMYCIN TABLET, FILM COATED [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20140102_b333961e-22af-41de-9fad-192d56af8d38.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197516clarithromycin 250 MG Oral TabletPSNb333961e-22af-41de-9fad-192d56af8d381
197517clarithromycin 500 MG Oral TabletPSNb333961e-22af-41de-9fad-192d56af8d381
197516clarithromycin 250 MG Oral TabletSCDb333961e-22af-41de-9fad-192d56af8d381
197517clarithromycin 500 MG Oral TabletSCDb333961e-22af-41de-9fad-192d56af8d381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-631-203326106312020 in 1 BOTTLE, PLASTICHistorical