AZITHROMYCIN

Product NDC
50090-6296
11-digit product format
500906296
Labeler code
50090
Product ID
50090-6296_52447b25-1d4a-4d01-a863-83d92bf33388
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azithromycin
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA207531
Marketing category
ANDA
Marketing start
2018-04-10
Substance
AZITHROMYCIN MONOHYDRATE
Active strength
200 mg/5mL
Pharmacologic classes
Macrolide Antimicrobial [EPC], Macrolides [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
AZITHROMYCIN
Listing expiration
2027-12-31

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
50090-6296-0AZITHROMYCIN15 mL in 1 BOTTLE, PLASTICPOWDER, FOR SUSPENSION157

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-6296AZITHROMYCIN POWDER, FOR SUSPENSION [A-S MEDICATION SOLUTIONS]4Current NDC, Legacy NDC, 1 package rows20230105_405ab07f-7d1d-4552-ad3b-2a03be8e9949.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141963azithromycin 200 MG in 5 mL Oral SuspensionPSN405ab07f-7d1d-4552-ad3b-2a03be8e99497
141963azithromycin 40 MG/ML Oral SuspensionSCD405ab07f-7d1d-4552-ad3b-2a03be8e99497
141963azithromycin 1200 MG per 30 ML Oral SuspensionSY405ab07f-7d1d-4552-ad3b-2a03be8e99497
141963azithromycin 200 MG per 5 ML Oral SuspensionSY405ab07f-7d1d-4552-ad3b-2a03be8e99497
141963azithromycin 600 MG per 15 ML Oral SuspensionSY405ab07f-7d1d-4552-ad3b-2a03be8e99497

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-6296-05009062960015 mL in 1 BOTTLE, PLASTIC (50090-6296-0) 15 ml2022-12-270000-00-00NoNoCurrent