FDA.reportPublic FDA data

Azithromycin

Product NDC
50090-1788
11-digit product format
500901788
Labeler code
50090
Product ID
50090-1788_b74e8a0c-b8f3-4afb-93fe-d1c7b050ee56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
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#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1788-02020-01-31C16284748780-19d75b9d0-f3d3-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, for oral use Initial U.S. Approval: 1991
50090-1788-12020-01-31C16284748780-19d75b9d0-f3d3-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, for oral use Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1788-0Azithromycin1 in 1 CARTONTABLET, FILM COATED14
50090-1788-0Azithromycin6 in 1 BLISTER PACKTABLET, FILM COATED64
50090-1788-1Azithromycin12 in 1 BLISTER PACKTABLET, FILM COATED124
50090-1788-1Azithromycin1 in 1 CARTONTABLET, FILM COATED14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-1788-0EA - Each50090-1788c6503b71-e609-4a07-8682-9f882f98f24e12018-10-11
50090-1788-1EA - Each50090-17885871e5f5-33bd-4961-9d1e-de592e9a34bf12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1788AZITHROMYCIN TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]4Legacy NDC, 4 package rows20180112_84aa116a-4aae-4e91-801f-1c5ced73ddce.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCK84aa116a-4aae-4e91-801f-1c5ced73ddce4
308460azithromycin 250 MG Oral TabletPSN84aa116a-4aae-4e91-801f-1c5ced73ddce4
749783azithromycin 250 MG Oral Tablet 6 Count PackPSN84aa116a-4aae-4e91-801f-1c5ced73ddce4
308460azithromycin 250 MG Oral TabletSCD84aa116a-4aae-4e91-801f-1c5ced73ddce4
749783azithromycin 250 MG Oral Tablet 6 Count PackSY84aa116a-4aae-4e91-801f-1c5ced73ddce4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50090-1788-0500901788001 in 1 CARTONHistorical
50090-1788-15009017880112 in 1 BLISTER PACKHistorical