FDA.reportPublic FDA data

Azithromycin

Product NDC
53002-0473
11-digit product format
530020473
Labeler code
53002
Product ID
53002-0473_0d5353f6-ab56-4925-8616-a2196a6c631b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA207398
Marketing category
ANDA
Marketing start
2018-07-05
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
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
53002-0473-12025-01-30C16284748780-1f386c64a-1aeb-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
53002-0473-12023-06-07C16284748780-1f386c64a-1aeb-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
53002-0473-12023-01-30C16284748780-1f386c64a-1aeb-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
53002-0473-1Azithromycin3 in 1 BLISTER PACKTABLET, FILM COATED33
53002-0473-1Azithromycin1 in 1 CARTONTABLET, FILM COATED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0473AZITHROMYCIN TABLET, FILM COATED [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 2 package rows20230609_1ef293bd-b99c-42ba-9c9b-6e0cd5e350b5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749780{3 (azithromycin 500 MG Oral Tablet) } PackGPCK1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
248656azithromycin 500 MG Oral TabletPSN1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
749780azithromycin 500 MG Oral Tablet 3 Count PackPSN1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
248656azithromycin 500 MG Oral TabletSCD1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
248656azithromycin 500 MG (as azithromycin monohydrate) Oral TabletSY1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53
749780azithromycin 500 MG Oral Tablet 3 Count PackSY1ef293bd-b99c-42ba-9c9b-6e0cd5e350b53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0473-1530020473011 BLISTER PACK in 1 CARTON (53002-0473-1) > 3 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2020-01-010000-00-00NoNoCurrent