FDA.reportPublic FDA data

Azithromycin Dihydrate

Product NDC
53002-0474
11-digit product format
530020474
Labeler code
53002
Product ID
53002-0474_a5e9c1c1-c956-4893-b7b5-32851ba5f862
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
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
53002-0474-12025-01-30C16284748780-1f386c64a-2cf6-0266-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
53002-0474-12023-06-08C16284748780-1f386c64a-2cf6-0266-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
53002-0474-12023-01-30C16284748780-1f386c64a-2cf6-0266-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
53002-0474-1Azithromycin Dihydrate3 in 1 BLISTER PACKTABLET, FILM COATED33
53002-0474-1Azithromycin Dihydrate1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0474AZITHROMYCIN DIHYDRATE TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_e1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCKe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
248656azithromycin 500 MG Oral TabletPSNe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
749780azithromycin 500 MG Oral Tablet 3 Count PackPSNe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
248656azithromycin 500 MG Oral TabletSCDe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSYe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3
749780azithromycin 500 MG Oral Tablet 3 Count PackSYe1f3e27c-75e6-44f8-b35e-fb0b68c8f5dc3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0474-1530020474011 BLISTER PACK in 1 CARTON (53002-0474-1) > 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-01-010000-00-00NoNoCurrent