NDC 70518-0505

Zithromax

Azithromycin Dihydrate

Zithromax is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Remedyrepack Inc.. The primary component is Azithromycin Dihydrate.

Product ID70518-0505_814d25a9-ed79-10e4-e053-2a91aa0aab8b
NDC70518-0505
Product TypeHuman Prescription Drug
Proprietary NameZithromax
Generic NameAzithromycin Dihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-05-09
Marketing CategoryNDA / NDA
Application NumberNDA050711
Labeler NameREMEDYREPACK INC.
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0505-1

4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0505-1)
Marketing Start Date2017-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0505-0 [70518050500]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050711
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-09
Marketing End Date2020-05-05

NDC 70518-0505-1 [70518050501]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050711
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:3045987c-1ae5-4a85-b69f-05c6b76d60e6
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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