FDA.reportPublic FDA data

Azithromycin

Product NDC
62135-705
11-digit product format
621350705
Labeler code
62135
Product ID
62135-705_15af5062-22b6-c8b6-e063-6294a90a7df3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
SUSPENSION
Route
ORAL
Labeler
Chartwell RX, LLC
Application
ANDA065488
Marketing category
ANDA
Marketing start
2015-05-15
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azithromycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZITHROMYCIN MONOHYDRATE200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiJTE4MNN1MD
Rxcui141963, 308459

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62135-705-43Azithromycin30 mL in 1 BOTTLESUSPENSION301
62135-705-51Azithromycin15 mL in 1 BOTTLESUSPENSION151
62135-705-52Azithromycin22.5 mL in 1 BOTTLESUSPENSION22.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62135-705AZITHROMYCIN SUSPENSION [CHARTWELL RX, LLC]1Current NDC, 3 package rows20240410_2c9de2e9-c20c-4660-a272-a22019f9fb02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN2c9de2e9-c20c-4660-a272-a22019f9fb021
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN2c9de2e9-c20c-4660-a272-a22019f9fb021
308459azithromycin 20 MG/ML Oral SuspensionSCD2c9de2e9-c20c-4660-a272-a22019f9fb021
141963azithromycin 40 MG/ML Oral SuspensionSCD2c9de2e9-c20c-4660-a272-a22019f9fb021
308459azithromycin 100 MG per 5 ML Oral SuspensionSY2c9de2e9-c20c-4660-a272-a22019f9fb021
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY2c9de2e9-c20c-4660-a272-a22019f9fb021
141963azithromycin 200 MG per 5 ML Oral SuspensionSY2c9de2e9-c20c-4660-a272-a22019f9fb021
141963azithromycin 600 MG per 15 ML Oral SuspensionSY2c9de2e9-c20c-4660-a272-a22019f9fb021

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62135-705-436213507054330 mL in 1 BOTTLE (62135-705-43) 30 ml2024-03-07NoNoCurrent
62135-705-516213507055115 mL in 1 BOTTLE (62135-705-51) 15 ml2024-03-07NoNoCurrent
62135-705-526213507055222.5 mL in 1 BOTTLE (62135-705-52) 22.5 ml2024-03-07NoNoCurrent