Azithromycin

Product NDC
45865-536
11-digit product format
458650536
Labeler code
45865
Product ID
45865-536_1eb8084b-68e2-3178-e054-00144ff88e88
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA065225
Marketing category
ANDA
Marketing start
2006-01-06
Marketing end
0000-00-00
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-536-06Azithromycin1 in 1 BOXTABLET, FILM COATED11
45865-536-06Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-536AZITHROMYCIN TABLET, FILM COATED [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 2 package rows20150902_1eb8084b-68e1-3178-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN1eb8084b-68e1-3178-e054-00144ff88e881
308460azithromycin 250 MG Oral TabletSCD1eb8084b-68e1-3178-e054-00144ff88e881

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-536-06458650536061 BLISTER PACK in 1 BOX (45865-536-06) > 6 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2006-01-060000-00-00NoNoCurrent