Azithromycin

Product NDC
50090-1868
11-digit product format
500901868
Labeler code
50090
Product ID
50090-1868_4ceb10f9-5c4f-4b5b-be5a-e9e58820558e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA065246
Marketing category
ANDA
Marketing start
2010-12-28
Substance
AZITHROMYCIN DIHYDRATE
Active strength
100 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 DIHYDRATE100 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
50090-1868-0Azithromycin15 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1516

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1868AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]16Current NDC, 1 package rows20240724_f97d2e7e-ccfd-4f04-85ba-549b37f6aa7b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308459azithromycin 100 MG in 5 mL Oral SuspensionPSNf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 200 MG in 5 mL Oral SuspensionPSNf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
308459azithromycin 20 MG/ML Oral SuspensionSCDf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 40 MG/ML Oral SuspensionSCDf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
308459azithromycin 100 MG per 5 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 1200 MG per 30 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 200 MG per 5 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16
141963azithromycin 600 MG per 15 ML Oral SuspensionSYf97d2e7e-ccfd-4f04-85ba-549b37f6aa7b16

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-1868-05009018680015 mL in 1 BOTTLE (50090-1868-0) 15 ml2015-06-10NoNoCurrent