FDA.reportPublic FDA data

Azithromycin

Product NDC
63187-093
11-digit product format
631870093
Labeler code
63187
Product ID
63187-093_9d10dacc-ad17-48ec-b037-94987b2c40bc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-17
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

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
63187-093-15Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION156
63187-093-22Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.56
63187-093-30Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-093AZITHROMYCIN POWDER, FOR SUSPENSION [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20240412_44134421-cb0b-4e85-a3c8-d58bdb476fad.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 40 MG/ML Oral SuspensionSCD44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 200 MG per 5 ML Oral SuspensionSY44134421-cb0b-4e85-a3c8-d58bdb476fad6
141963azithromycin 600 MG per 15 ML Oral SuspensionSY44134421-cb0b-4e85-a3c8-d58bdb476fad6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-093-156318700931515 mL in 1 BOTTLE (63187-093-15) 15 ml2014-07-010000-00-00NoNoCurrent
63187-093-226318700932222.5 mL in 1 BOTTLE (63187-093-22) 22.5 ml2024-04-03NoNoCurrent
63187-093-306318700933030 mL in 1 BOTTLE (63187-093-30) 30 ml2014-07-010000-00-00NoNoCurrent