NDC 43063-713

azithromycin monohydrate

Azithromycin Monohydrate

azithromycin monohydrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Pd-rx Pharmaceuticals, Inc.. The primary component is Azithromycin Monohydrate.

Product ID43063-713_82e68ac3-6d32-1c6e-e053-2991aa0a60c9
NDC43063-713
Product TypeHuman Prescription Drug
Proprietary Nameazithromycin monohydrate
Generic NameAzithromycin Monohydrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-08-18
Marketing CategoryANDA / ANDA
Application NumberANDA065399
Labeler NamePD-Rx Pharmaceuticals, Inc.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 43063-713-02

2 TABLET in 1 BOTTLE, PLASTIC (43063-713-02)
Marketing Start Date2016-10-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 43063-713-79 [43063071379]

azithromycin monohydrate TABLET
Marketing CategoryANDA
Application NumberANDA065399
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-07

NDC 43063-713-03 [43063071303]

azithromycin monohydrate TABLET
Marketing CategoryANDA
Application NumberANDA065399
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-07

NDC 43063-713-07 [43063071307]

azithromycin monohydrate TABLET
Marketing CategoryANDA
Application NumberANDA065399
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-29

NDC 43063-713-05 [43063071305]

azithromycin monohydrate TABLET
Marketing CategoryANDA
Application NumberANDA065399
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-05-18

NDC 43063-713-02 [43063071302]

azithromycin monohydrate TABLET
Marketing CategoryANDA
Application NumberANDA065399
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-10-07

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/1

OpenFDA Data

SPL SET ID:a3262259-879f-42ab-b702-06e6deebe69b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656
    • UPC Code
  • 0343063713020

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]

    NDC Crossover Matching brand name "azithromycin monohydrate" or generic name "Azithromycin Monohydrate"

    NDCBrand NameGeneric Name
    0904-6708azithromycin monohydrateazithromycin monohydrate
    0904-6909azithromycin monohydrateazithromycin monohydrate
    43063-713azithromycin monohydrateazithromycin monohydrate
    43063-715azithromycin monohydrateazithromycin monohydrate
    43063-728azithromycin monohydrateazithromycin monohydrate
    48792-7869azithromycin monohydrateazithromycin monohydrate
    48792-7870azithromycin monohydrateazithromycin monohydrate
    50436-3136azithromycin monohydrateazithromycin monohydrate
    68071-3187azithromycin monohydrateazithromycin monohydrate
    68071-3168azithromycin monohydrateazithromycin monohydrate
    68071-3136azithromycin monohydrateazithromycin monohydrate
    68071-3169azithromycin monohydrateazithromycin monohydrate
    68071-4214azithromycin monohydrateazithromycin monohydrate
    68071-4230azithromycin monohydrateazithromycin monohydrate
    68083-199Azithromycin monohydrateAzithromycin monohydrate
    68180-160azithromycin monohydrateazithromycin monohydrate
    68180-162azithromycin monohydrateazithromycin monohydrate
    68180-161azithromycin monohydrateazithromycin monohydrate
    69677-129Azithromycin MonohydrateAzithromycin Monohydrate
    70518-0736azithromycin monohydrateazithromycin monohydrate
    70518-0803azithromycin monohydrateazithromycin monohydrate
    71205-119azithromycin monohydrateazithromycin monohydrate
    53217-403azithromycin monohydrateazithromycin monohydrate
    53217-327azithromycin monohydrateazithromycin monohydrate
    55700-432azithromycin monohydrateazithromycin monohydrate
    57297-160azithromycin monohydrateazithromycin monohydrate
    57297-161azithromycin monohydrateazithromycin monohydrate
    57297-162azithromycin monohydrateazithromycin monohydrate
    60687-282Azithromycin MonohydrateAzithromycin Monohydrate
    60687-271Azithromycin MonohydrateAzithromycin Monohydrate
    60687-314Azithromycin MonohydrateAzithromycin Monohydrate
    61919-096AZITHROMYCIN MONOHYDRATEAZITHROMYCIN MONOHYDRATE
    61919-260AZITHROMYCIN MONOHYDRATEAZITHROMYCIN MONOHYDRATE
    65162-760Azithromycin MonohydrateAzithromycin Monohydrate
    65162-708Azithromycin MonohydrateAzithromycin Monohydrate
    65162-758Azithromycin MonohydrateAzithromycin Monohydrate
    65162-759Azithromycin MonohydrateAzithromycin Monohydrate
    17478-307AzaSITEAzithromycin Monohydrate
    0093-7148AzithromycinAzithromycin Monohydrate
    0093-7149AzithromycinAzithromycin Monohydrate
    0527-2370azithromycinAZITHROMYCIN MONOHYDRATE
    0527-2381azithromycinAZITHROMYCIN MONOHYDRATE
    0527-2395azithromycinAZITHROMYCIN MONOHYDRATE
    21695-548AzithromycinAzithromycin monohydrate
    21695-549AzithromycinAzithromycin monohydrate
    48792-7871azithromycinAZITHROMYCIN MONOHYDRATE
    51672-4200AzithromycinAZITHROMYCIN MONOHYDRATE
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