NDC 67457-860

Azithromycin

Azithromycin

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

Product ID67457-860_0f010c11-6d21-4f47-aed7-5f7736b3e2a1
NDC67457-860
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-06-27
Marketing CategoryANDA / ANDA
Application NumberANDA065506
Labeler NameMylan Institutional LLC
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength500 mg/5mL
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-860-50

10 VIAL in 1 CARTON (67457-860-50) > 5 mL in 1 VIAL (67457-860-00)
Marketing Start Date2019-06-27
Marketing End Date2021-11-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-860-00 [67457086000]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-08-02

NDC 67457-860-50 [67457086050]

Azithromycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA065506
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-06-27

Drug Details

OpenFDA Data

SPL SET ID:0f010c11-6d21-4f47-aed7-5f7736b3e2a1
Manufacturer
UNII

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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