NDC 63323-398

Azithromycin

Azithromycin Monohydrate

Azithromycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Azithromycin Monohydrate.

Product ID63323-398_23cbdaeb-6dc7-42a8-ac59-fcccd1789c7e
NDC63323-398
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin Monohydrate
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2006-03-20
Marketing CategoryANDA / ANDA
Application NumberANDA065179
Labeler NameFresenius Kabi USA, LLC
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength500 mg/5mL
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 63323-398-10

10 VIAL in 1 TRAY (63323-398-10) > 5 mL in 1 VIAL (63323-398-01)
Marketing Start Date2006-03-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-398-12 [63323039812]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065179
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-03-20

NDC 63323-398-41 [63323039841]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-11-19

NDC 63323-398-14 [63323039814]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065179
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-03-20

NDC 63323-398-01 [63323039801]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065179
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-10-02

NDC 63323-398-10 [63323039810]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065179
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-03-20

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/5mL

OpenFDA Data

SPL SET ID:9ad099d5-5c57-4855-98a4-e03fb4629dbf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1668238
    • UPC Code
  • 0363323398149

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]

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

    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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