NDC 0069-4061

Zithromax

Azithromycin Dihydrate

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

Product ID0069-4061_0a7a028c-ef61-4dcc-8ab6-f20cf8270a86
NDC0069-4061
Product TypeHuman Prescription Drug
Proprietary NameZithromax
Generic NameAzithromycin Dihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-05-17
Marketing CategoryNDA / NDA
Application NumberNDA050711
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0069-4061-01

30 TABLET, FILM COATED in 1 BOTTLE (0069-4061-01)
Marketing Start Date2020-05-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-4061-01 [00069406101]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050711
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-17
Marketing End Date2019-05-17

NDC 0069-4061-75 [00069406175]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050711
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-17
Marketing End Date2019-05-17

NDC 0069-4061-89 [00069406189]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050711
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-17
Marketing End Date2019-05-17

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:db52b91e-79f7-4cc1-9564-f2eee8e31c45
Manufacturer
UNII
UPC Code
  • 0300693060306
  • 0300693070305
  • 0300693140190
  • 0300693130191
  • 0300693120192
  • 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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