Azithromycin

Product NDC
76413-153
11-digit product format
764130153
Labeler code
76413
Product ID
76413-153_96c9d895-d470-4ecf-a346-ff9c951d56a5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Central Texas Community Health Centers
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
2019-12-31
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
76413-153-04Azithromycin4 in 1 BOTTLETABLET, FILM COATED42
76413-153-06Azithromycin6 in 1 BOX, UNIT-DOSETABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76413-153AZITHROMYCIN TABLET, FILM COATED [CENTRAL TEXAS COMMUNITY HEALTH CENTERS]2Legacy NDC, 2 package rows20170921_bb23de1f-6c42-4b36-a840-a377f5082683.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSNbb23de1f-6c42-4b36-a840-a377f50826832
308460azithromycin 250 MG Oral TabletSCDbb23de1f-6c42-4b36-a840-a377f50826832

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
76413-153-04764130153044 in 1 BOTTLEHistorical
76413-153-06764130153066 in 1 BOX, UNIT-DOSEHistorical