NDC 70518-0336

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 ID70518-0336_83d27268-3433-5f0e-e053-2991aa0a194e
NDC70518-0336
Product TypeHuman Prescription Drug
Proprietary NameZithromax
Generic NameAzithromycin Dihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-03-17
Marketing CategoryNDA / NDA
Application NumberNDA050784
Labeler NameREMEDYREPACK INC.
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0336-0

2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0336-0)
Marketing Start Date2017-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0336-1 [70518033601]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050784
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-10

NDC 70518-0336-0 [70518033600]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050784
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-20

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

OpenFDA Data

SPL SET ID:fbb9b312-0664-4a6f-9111-69a7749311e0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 226827
  • 248656

    • 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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