FDA.reportPublic FDA data

azithromycin dihydrate

Product NDC
50090-2334
11-digit product format
500902334
Labeler code
50090
Product ID
50090-2334_fa0d2fbf-b36a-459e-a874-56b6ae0b2f99
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin dihydrate
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065399
Marketing category
ANDA
Marketing start
2015-08-18
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
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2334-02020-01-31C16284748780-19d75b9d0-3640-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991
50090-2334-12020-01-31C16284748780-19d75b9d0-3640-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN TABLETS safely and effectively. See full prescribing information for AZITHROMYCIN TABLETS. AZITHROMYCIN tablets, 250 mg and 500 mg, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2334-0azithromycin dihydrate5 in 1 BOTTLETABLET56
50090-2334-1azithromycin dihydrate1 in 1 BOTTLETABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2334-0EA - Each50090-233464f0ebf4-b579-4f35-a53a-ad9939c6dfd612019-02-13
50090-2334-1EA - Each50090-233464fda98e-d091-4395-b073-326d15c9368b12019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2334AZITHROMYCIN DIHYDRATE TABLET [A-S MEDICATION SOLUTIONS]6Legacy NDC, 2 package rows20190225_de58d218-7127-46f2-8578-e7a5c02140d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSNde58d218-7127-46f2-8578-e7a5c02140d16
248656azithromycin 500 MG Oral TabletSCDde58d218-7127-46f2-8578-e7a5c02140d16
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYde58d218-7127-46f2-8578-e7a5c02140d16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-2334-0500902334005 in 1 BOTTLEHistorical
50090-2334-1500902334011 in 1 BOTTLEHistorical