ZITHROMAX

Product NDC
61919-555
11-digit product format
619190555
Labeler code
61919
Product ID
61919-555_9cad9864-bc9d-94f9-e053-2a95a90a04a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
DIRECT RX
Application
ANDA065404
Marketing category
ANDA
Marketing start
2016-03-02
Marketing end
0000-00-00
Substance
AZITHROMYCIN ANHYDROUS
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC],Macrolides [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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
61919-555-062023-01-30C16284748780-1f386c64a-3922-0266-e053-dadaa90a7c1aAZITHROMYCIN 250mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-555-06ZITHROMAX1 in 1 BOTTLETABLET, FILM COATED12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-555-06EA - Each61919-555591c9d06-1c88-4586-86c1-aeeefb444cc412016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-555ZITHROMAX (AZITHROMYCIN) TABLET, FILM COATED [DIRECT RX]2Legacy NDC, 1 package rows20200131_330a082d-57b2-2bf5-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308460azithromycin 250 MG Oral TabletPSN330a082d-57b2-2bf5-e054-00144ff88e882
212446Zithromax 250 MG Oral TabletPSN330a082d-57b2-2bf5-e054-00144ff88e882
212446azithromycin 250 MG Oral Tablet [Zithromax]SBD330a082d-57b2-2bf5-e054-00144ff88e882
308460azithromycin 250 MG Oral TabletSCD330a082d-57b2-2bf5-e054-00144ff88e882
212446Zithromax 250 MG Oral TabletSY330a082d-57b2-2bf5-e054-00144ff88e882

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
61919-555-06619190555061 TABLET, FILM COATED in 1 BOTTLE (61919-555-06) 2016-03-020000-00-00NoNoCurrent