FDA.reportPublic FDA data

Azithromycin

Product NDC
59651-008
11-digit product format
596510008
Labeler code
59651
Product ID
59651-008_c2e840f6-e3a8-4524-a36e-2ce70d67cf2a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA209201
Marketing category
ANDA
Marketing start
2018-10-09
Substance
AZITHROMYCIN DIHYDRATE
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 DIHYDRATE200 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5FD1131I7S
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
59651-008-15Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION158
59651-008-15Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION18
59651-008-23Azithromycin22.5 mL in 1 BOTTLEPOWDER, FOR SUSPENSION22.58
59651-008-23Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION18
59651-008-30Azithromycin30 mL in 1 BOTTLEPOWDER, FOR SUSPENSION308
59651-008-30Azithromycin1 in 1 CARTONPOWDER, FOR SUSPENSION18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-008-15ML - Milliliter59651-008b82fc9d8-1ead-4aaa-b1ef-21d5845370c712019-01-24
59651-008-23ML - Milliliter59651-00857233489-6883-47b0-8ee2-8bae5c6acf5212019-01-24
59651-008-30ML - Milliliter59651-008d672dd0b-5594-4228-a56b-13ca7e7e928012019-01-24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-008AZITHROMYCIN POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]8Current NDC, Legacy NDC, 6 package rows20220523_3c902990-b870-4725-b9fe-76b8be633e1c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSN3c902990-b870-4725-b9fe-76b8be633e1c8
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN3c902990-b870-4725-b9fe-76b8be633e1c8
308459azithromycin 20 MG/ML Oral SuspensionSCD3c902990-b870-4725-b9fe-76b8be633e1c8
141963azithromycin 40 MG/ML Oral SuspensionSCD3c902990-b870-4725-b9fe-76b8be633e1c8
308459azithromycin 100 MG per 5 ML Oral SuspensionSY3c902990-b870-4725-b9fe-76b8be633e1c8
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY3c902990-b870-4725-b9fe-76b8be633e1c8
141963azithromycin 200 MG per 5 ML Oral SuspensionSY3c902990-b870-4725-b9fe-76b8be633e1c8
141963azithromycin 600 MG per 15 ML Oral SuspensionSY3c902990-b870-4725-b9fe-76b8be633e1c8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-008-15596510008151 BOTTLE in 1 CARTON (59651-008-15) / 15 mL in 1 BOTTLE1 bottle2018-10-090000-00-00NoNoCurrent
59651-008-23596510008231 BOTTLE in 1 CARTON (59651-008-23) / 22.5 mL in 1 BOTTLE1 bottle2018-10-090000-00-00NoNoCurrent
59651-008-30596510008301 BOTTLE in 1 CARTON (59651-008-30) / 30 mL in 1 BOTTLE1 bottle2018-10-090000-00-00NoNoCurrent