NDC 21695-549

Azithromycin

Azithromycin Monohydrate

Azithromycin is a Oral Powder, For Suspension in the Human Prescription Drug category. It is labeled and distributed by Rebel Distributors Corp.. The primary component is Azithromycin Monohydrate.

Product ID21695-549_72cd7af3-24c4-4a06-b079-ba47d07d7253
NDC21695-549
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin Monohydrate
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2008-06-24
Marketing CategoryANDA / ANDA
Application NumberANDA065419
Labeler NameRebel Distributors Corp.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength200 mg/5mL
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 21695-549-15

15 mL in 1 BOTTLE (21695-549-15)
Marketing Start Date2008-06-24
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 21695-549-30 [21695054930]

Azithromycin POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-10-21
Inactivation Date2019-09-24

NDC 21695-549-15 [21695054915]

Azithromycin POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-06-24
Inactivation Date2019-09-24

NDC 21695-549-22 [21695054922]

Azithromycin POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065419
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-10-21
Inactivation Date2019-09-24

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE200 mg/5mL

OpenFDA Data

SPL SET ID:58b72e4c-f419-4a70-b894-93a5804d9993
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308459
  • 141963

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [Chemical/Ingredient]

    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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