NDC 62756-512

Azithromycin

Azithromycin

Azithromycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Azithromycin Monohydrate.

Product ID62756-512_822e078d-ea93-4a4b-b640-2cc7174f5b52
NDC62756-512
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2020-07-15
Marketing CategoryANDA / ANDA
Application NumberANDA090923
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength500 mg/5mL
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 62756-512-44

10 VIAL in 1 PACKAGE (62756-512-44) > 5 mL in 1 VIAL (62756-512-40)
Marketing Start Date2020-07-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-512-44 [62756051244]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-03
Inactivation Date2020-01-31

NDC 62756-512-40 [62756051240]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA090923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2013-04-03

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/5mL

OpenFDA Data

SPL SET ID:6a22beb6-57e8-480d-97b5-44d9dbfabf93
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1668238
  • UPC Code
  • 0362756512405
  • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]

    NDC Crossover Matching brand name "Azithromycin" or generic name "Azithromycin"

    NDCBrand NameGeneric Name
    0093-2026AzithromycinAzithromycin
    0093-2027AzithromycinAzithromycin
    0093-7146AzithromycinAzithromycin
    0093-7147AzithromycinAzithromycin
    0093-7148AzithromycinAzithromycin Monohydrate
    0093-7149AzithromycinAzithromycin Monohydrate
    0093-7169AzithromycinAzithromycin
    0409-0144AzithromycinAZITHROMYCIN
    0527-2370azithromycinAZITHROMYCIN MONOHYDRATE
    0527-2381azithromycinAZITHROMYCIN MONOHYDRATE
    0527-2395azithromycinAZITHROMYCIN MONOHYDRATE
    0781-1496AzithromycinAzithromycin
    0781-1497AzithromycinAzithromycin
    0781-1941AzithromycinAzithromycin
    0781-5776AzithromycinAzithromycin
    0781-5789AzithromycinAzithromycin
    68071-1323AzithromycinAzithromycin
    68071-1528AzithromycinAzithromycin
    68071-1584AzithromycinAzithromycin
    68071-1527AzithromycinAzithromycin
    68071-1873AzithromycinAzithromycin
    68071-1392AzithromycinAzithromycin
    68071-1605AzithromycinAzithromycin
    68071-3006AzithromycinAzithromycin
    68071-4106AzithromycinAzithromycin
    68071-4255AzithromycinAzithromycin
    68071-4364AzithromycinAzithromycin
    68071-4680AzithromycinAzithromycin
    68071-4785AzithromycinAzithromycin
    68071-4795AZITHROMYCINAZITHROMYCIN
    68071-4786AzithromycinAzithromycin
    68071-4774AzithromycinAzithromycin
    68071-4711AzithromycinAzithromycin
    68071-4773AZITHROMYCINAZITHROMYCIN
    68071-4779AzithromycinAzithromycin
    68258-3051azithromycinazithromycin
    68258-3012AZITHROMYCINAZITHROMYCIN
    68788-7082AzithromycinAzithromycin
    68788-0713azithromycinazithromycin
    68788-8939AzithromycinAzithromycin
    68788-9046AzithromycinAzithromycin
    68788-9077AzithromycinAzithromycin
    68788-8947AzithromycinAzithromycin
    68788-9958AzithromycinAzithromycin
    68788-7066AzithromycinAzithromycin
    68788-9045AzithromycinAzithromycin
    68788-9311AzithromycinAzithromycin
    68788-9038azithromycinazithromycin
    68788-9078AzithromycinAzithromycin
    68788-9959AzithromycinAzithromycin

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