azithromycin

Product NDC
53002-2225
11-digit product format
530022225
Labeler code
53002
Product ID
53002-2225_03c71cee-5bd5-4245-8ee9-eb9166db6663
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AZITHROMYCIN
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
NDA050693
Marketing category
NDA
Marketing start
1999-02-12
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
1 g/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
53002-2225-12025-01-30C16284748780-19d75b9d0-e87e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
53002-2225-12023-06-07C16284748780-19d75b9d0-e87e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
53002-2225-12023-01-30C16284748780-19d75b9d0-e87e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
53002-2225-12020-12-15C16284748780-19d75b9d0-e87e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
53002-2225-12020-01-31C16284748780-19d75b9d0-e87e-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use AZITHROMYCIN safely and effectively. See full prescribing information for AZITHROMYCIN. AZITHROMYCIN 600 mg tablets, for oral use AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2225-1azithromycin1 in 1 PACKETPOWDER, FOR SUSPENSION15
53002-2225-1azithromycin3 in 1 BOXPOWDER, FOR SUSPENSION35

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2225AZITHROMYCIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 2 package rows20230609_0188acfd-cc89-4486-8bcf-93a53340dfca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
861416azithromycin 1 GM Powder for Oral SuspensionPSN0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1000 MG Powder for Oral SuspensionSCD0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1 GM Powder for Oral SuspensionSY0188acfd-cc89-4486-8bcf-93a53340dfca5
861416azithromycin 1000 MG Powder for Oral SuspensionSY0188acfd-cc89-4486-8bcf-93a53340dfca5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2225-1530022225013 PACKET in 1 BOX (53002-2225-1) > 1 POWDER, FOR SUSPENSION in 1 PACKET3 packet2018-10-010000-00-00NoNoCurrent