FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
53002-4228
11-digit product format
530024228
Labeler code
53002
Product ID
53002-4228_8e868fbf-090a-4676-a45e-94246f344607
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA208250
Marketing category
ANDA
Marketing start
2019-07-01
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
250 mg/1
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
bc5cb41f-7cc8-4f57-b1a7-5eaf0458a401Product name920200616
a2cbe82e-b432-4f71-954b-75e9214e8567Product name320200612
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
371533fa-efb3-4c48-b5e4-60179db407f3Product name320190124
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53002-4228-12025-01-30C16284748780-12cef2736-aafe-d83d-e063-dadaa90ab31fThese 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
53002-4228-1Azithromycin Dihydrate6 in 1 DOSE PACKTABLET, FILM COATED62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-4228AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]2Legacy NDC, 1 package rows20220420_f241b712-d563-45da-8708-8c291abb3b2d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749783{6 (azithromycin 250 MG Oral Tablet) } PackGPCKf241b712-d563-45da-8708-8c291abb3b2d2
308460azithromycin 250 MG Oral TabletPSNf241b712-d563-45da-8708-8c291abb3b2d2
749783azithromycin 250 MG Oral Tablet 6 Count PackPSNf241b712-d563-45da-8708-8c291abb3b2d2
308460azithromycin 250 MG Oral TabletSCDf241b712-d563-45da-8708-8c291abb3b2d2
749783azithromycin 250 MG Oral Tablet 6 Count PackSYf241b712-d563-45da-8708-8c291abb3b2d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-4228-1530024228016 TABLET, FILM COATED in 1 DOSE PACK (53002-4228-1) 2021-12-210000-00-00NoNoCurrent