NDC 61919-555

ZITHROMAX

Azithromycin

ZITHROMAX is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Direct Rx. The primary component is Azithromycin Anhydrous.

Product ID61919-555_330a082d-57b3-2bf5-e054-00144ff88e88
NDC61919-555
Product TypeHuman Prescription Drug
Proprietary NameZITHROMAX
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2016-03-02
Marketing CategoryANDA / ANDA
Application NumberANDA065404
Labeler NameDIRECT RX
Substance NameAZITHROMYCIN ANHYDROUS
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 61919-555-06

1 TABLET, FILM COATED in 1 BOTTLE (61919-555-06)
Marketing Start Date2016-03-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-555-06 [61919055506]

ZITHROMAX TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065404
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-03-02

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN ANHYDROUS250 mg/1

OpenFDA Data

SPL SET ID:330a082d-57b2-2bf5-e054-00144ff88e88
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"

    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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