NDC 17478-307

AzaSITE

Azithromycin Monohydrate

AzaSITE is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Akorn. The primary component is Azithromycin Monohydrate.

Product ID17478-307_1a5cc030-9de6-4918-a165-ccad89d6f2ad
NDC17478-307
Product TypeHuman Prescription Drug
Proprietary NameAzaSITE
Generic NameAzithromycin Monohydrate
Dosage FormSolution/ Drops
Route of AdministrationOPHTHALMIC
Marketing Start Date2014-05-14
Marketing CategoryNDA / NDA
Application NumberNDA050810
Labeler NameAkorn
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength10 mg/mL
Pharm ClassesMacrolide Antimicrobial [EPC], Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 17478-307-03

1 BOTTLE, DROPPER in 1 CARTON (17478-307-03) > 2.5 mL in 1 BOTTLE, DROPPER
Marketing Start Date2014-05-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17478-307-01 [17478030701]

AzaSITE SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA050810
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-14

NDC 17478-307-03 [17478030703]

AzaSITE SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA050810
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-05-14

NDC 17478-307-04 [17478030704]

AzaSITE SOLUTION/ DROPS
Marketing CategoryNDA
Application NumberNDA050810
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-05-14

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE10 mg/mL

OpenFDA Data

SPL SET ID:14ae4c07-b042-452a-b069-2b41bc646e04
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 706868
  • 706872
    • UPC Code
  • 0317478307037

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]
    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]

    Medicade Reported Pricing

    17478030703 AZASITE 1% EYE DROPS

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "AzaSITE" or generic name "Azithromycin Monohydrate"

    NDCBrand NameGeneric Name
    17478-307AzaSITEAzithromycin Monohydrate
    0093-7148AzithromycinAzithromycin Monohydrate
    0093-7149AzithromycinAzithromycin Monohydrate
    0527-2370azithromycinAZITHROMYCIN MONOHYDRATE
    0527-2381azithromycinAZITHROMYCIN MONOHYDRATE
    0527-2395azithromycinAZITHROMYCIN MONOHYDRATE
    21695-548AzithromycinAzithromycin monohydrate
    21695-549AzithromycinAzithromycin monohydrate
    48792-7871azithromycinAZITHROMYCIN MONOHYDRATE
    51672-4200AzithromycinAZITHROMYCIN MONOHYDRATE
    0904-6708azithromycin monohydrateazithromycin monohydrate
    0904-6909azithromycin monohydrateazithromycin monohydrate
    43063-713azithromycin monohydrateazithromycin monohydrate
    43063-715azithromycin monohydrateazithromycin monohydrate
    43063-728azithromycin monohydrateazithromycin monohydrate
    48792-7869azithromycin monohydrateazithromycin monohydrate
    48792-7870azithromycin monohydrateazithromycin monohydrate
    50436-3136azithromycin monohydrateazithromycin monohydrate

    Trademark Results [AzaSITE]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    AZASITE
    AZASITE
    78426374 3345071 Live/Registered
    INSITE VISION INCORPORATED
    2004-05-27
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