Azithromycin Dihydrate

Product NDC
50090-4606
11-digit product format
500904606
Labeler code
50090
Product ID
50090-4606_67b167e7-65fb-477e-8bd1-450462814491
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA208249
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
500 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
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
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
50090-4606-0Azithromycin Dihydrate2 in 1 BOTTLETABLET, FILM COATED25

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4606AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]5Legacy NDC, 1 package rows20211029_fe52f9fe-da0f-47e5-899e-a5513fb7688d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNfe52f9fe-da0f-47e5-899e-a5513fb7688d5
248656azithromycin 500 MG Oral TabletSCDfe52f9fe-da0f-47e5-899e-a5513fb7688d5
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYfe52f9fe-da0f-47e5-899e-a5513fb7688d5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50090-4606-0500904606002 TABLET, FILM COATED in 1 BOTTLE (50090-4606-0) 2019-10-140000-00-00NoNoCurrent