NDC 50090-0603

Zithromax

Azithromycin Dihydrate

Zithromax is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Azithromycin Dihydrate.

Product ID50090-0603_c1f2370f-8885-46e8-8130-6ad81ced0747
NDC50090-0603
Product TypeHuman Prescription Drug
Proprietary NameZithromax
Generic NameAzithromycin Dihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date1996-07-18
Marketing CategoryNDA / NDA
Application NumberNDA050711
Labeler NameA-S Medication Solutions
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-0603-0

3 BLISTER PACK in 1 BOX (50090-0603-0) > 6 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2014-11-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-0603-0 [50090060300]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050711
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2014-11-28

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:451ec78c-8d26-43e5-a373-9115c337570a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 212446
  • 308460

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]

    NDC Crossover Matching brand name "Zithromax" or generic name "Azithromycin Dihydrate"

    NDCBrand NameGeneric Name
    0069-0400Zithromaxazithromycin dihydrate
    0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATE
    0069-3060Zithromaxazithromycin dihydrate
    0069-3070Zithromaxazithromycin dihydrate
    0069-3080ZITHROMAXAZITHROMYCIN DIHYDRATE
    0069-3110Zithromaxazithromycin dihydrate
    70518-0249ZithromaxZithromax
    70518-0336ZithromaxZithromax
    70518-0505ZithromaxZithromax
    0069-3120ZithromaxZithromax
    0069-3130ZithromaxZithromax
    0069-3140ZithromaxZithromax
    0069-3150ZithromaxZithromax
    50090-0603ZithromaxZithromax
    55154-2713ZithromaxZithromax
    61919-555ZITHROMAXZITHROMAX
    0069-4061ZithromaxZithromax
    0069-9500ZithromaxZithromax

    Trademark Results [Zithromax]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZITHROMAX
    ZITHROMAX
    74034510 1702392 Live/Registered
    PFIZER INC.
    1990-03-05
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