NDC 0069-3150

Zithromax

Azithromycin Dihydrate

Zithromax is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Pfizer Laboratories Div Pfizer Inc. The primary component is Azithromycin Dihydrate.

Product ID0069-3150_0a02750c-0ed6-40a4-8945-ef9bad7059f8
NDC0069-3150
Product TypeHuman Prescription Drug
Proprietary NameZithromax
Generic NameAzithromycin Dihydrate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date1997-01-30
Marketing CategoryNDA / NDA
Application NumberNDA050733
Labeler NamePfizer Laboratories Div Pfizer Inc
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength500 mg/5mL
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0069-3150-83

10 VIAL in 1 CARTON (0069-3150-83) > 5 mL in 1 VIAL (0069-3150-84)
Marketing Start Date1997-01-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0069-3150-84 [00069315084]

Zithromax INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA050733
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-07-10

NDC 0069-3150-83 [00069315083]

Zithromax INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA050733
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-01-30

NDC 0069-3150-14 [00069315014]

Zithromax INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryNDA
Application NumberNDA050733
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1997-01-30

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/5mL

OpenFDA Data

SPL SET ID:3b631aa1-2d46-40bc-a614-d698301ea4f9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1668240
  • 1668238
  • 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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