FDA.reportPublic FDA data

Azithromycin

Product NDC
53002-2230
11-digit product format
530022230
Labeler code
53002
Product ID
53002-2230_de55fcee-a5e4-4aa4-a30b-adc5769be6bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-17
Marketing end
0000-00-00
Substance
AZITHROMYCIN DIHYDRATE
Active strength
200 mg/5mL
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
53002-2230-12023-01-30C16284748780-1f386c649-c53c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
53002-2230-22023-01-30C16284748780-1f386c649-c53c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991
53002-2230-32023-01-30C16284748780-1f386c649-c53c-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use AZITHROMYCIN FOR ORAL SUSPENSION safely and effectively. See full prescribing information for AZITHROMYCIN FOR ORAL SUSPENSION. AZITHROMYCIN for oral suspension Initial U.S. Approval: 1991

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-2230-1Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION153
53002-2230-2Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.53
53002-2230-3Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-2230AZITHROMYCIN POWDER, FOR SUSPENSION [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 3 package rows20210105_989174d7-4201-421f-a984-9d87b7f134e4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN989174d7-4201-421f-a984-9d87b7f134e43
141963azithromycin 40 MG/ML Oral SuspensionSCD989174d7-4201-421f-a984-9d87b7f134e43
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY989174d7-4201-421f-a984-9d87b7f134e43
141963azithromycin 200 MG per 5 ML Oral SuspensionSY989174d7-4201-421f-a984-9d87b7f134e43
141963azithromycin 600 MG per 15 ML Oral SuspensionSY989174d7-4201-421f-a984-9d87b7f134e43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-2230-15300222300115 mL in 1 BOTTLE (53002-2230-1) 15 ml2018-10-010000-00-00NoNoCurrent
53002-2230-25300222300222.5 mL in 1 BOTTLE (53002-2230-2) 22.5 ml2018-10-010000-00-00NoNoCurrent
53002-2230-35300222300330 mL in 1 BOTTLE (53002-2230-3) 30 ml2018-10-010000-00-00NoNoCurrent