NDC 0069-3070

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 ID0069-3070_0a7a028c-ef61-4dcc-8ab6-f20cf8270a86
NDC0069-3070
Product TypeHuman Prescription Drug
Proprietary NameZithromax
Generic NameAzithromycin Dihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2002-05-24
Marketing CategoryNDA / NDA
Application NumberNDA050784
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0069-3070-30

30 TABLET, FILM COATED in 1 BOTTLE (0069-3070-30)
Marketing Start Date2002-05-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-3070-86 [00069307086]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050784
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-05-24

NDC 0069-3070-30 [00069307030]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050784
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-05-24

NDC 0069-3070-75 [00069307075]

Zithromax TABLET, FILM COATED
Marketing CategoryNDA
Application NumberNDA050784
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2002-05-24

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

OpenFDA Data

SPL SET ID:db52b91e-79f7-4cc1-9564-f2eee8e31c45
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 226827
  • 248656
  • 750149
  • 141963
  • 750157
  • 212446
  • 211307
  • 308459
  • 105260
  • 749780
  • 749783
  • 308460
    • 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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