FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
53002-7221
11-digit product format
530027221
Labeler code
53002
Product ID
53002-7221_7a09c6b7-a47f-46dc-a381-bfaa7f1ef652
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin Dihydrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
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
2021-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
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
53002-7221-22025-01-30C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-52025-01-30C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-62025-01-30C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-22023-06-07C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-52023-06-07C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-62023-06-07C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-22023-01-30C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-52023-01-30C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-62023-01-30C16284748780-1f386c649-ad11-0266-e053-dadaa90a7c1aThese 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
53002-7221-2Azithromycin Dihydrate2 in 1 BOTTLETABLET, FILM COATED23
53002-7221-5Azithromycin Dihydrate5 in 1 BOTTLETABLET, FILM COATED53
53002-7221-6Azithromycin Dihydrate6 in 1 BOTTLETABLET, FILM COATED63

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-7221AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20230609_00dab70c-53ab-4a08-a6f0-1d78cbe43926.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248656azithromycin 500 MG Oral TabletPSN00dab70c-53ab-4a08-a6f0-1d78cbe439263
248656azithromycin 500 MG Oral TabletSCD00dab70c-53ab-4a08-a6f0-1d78cbe439263
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY00dab70c-53ab-4a08-a6f0-1d78cbe439263

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53002-7221-2530027221022 TABLET, FILM COATED in 1 BOTTLE (53002-7221-2) 2020-01-010000-00-00NoNoCurrent
53002-7221-5530027221055 TABLET, FILM COATED in 1 BOTTLE (53002-7221-5) 2020-01-010000-00-00NoNoCurrent
53002-7221-6530027221066 TABLET, FILM COATED in 1 BOTTLE (53002-7221-6) 2020-01-010000-00-00NoNoCurrent