NDC 68788-9046

Azithromycin

Azithromycin Monohydrate

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

Product ID68788-9046_10a31bb9-d93b-44ee-98d2-f4d24aab5680
NDC68788-9046
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin Monohydrate
Dosage FormPowder, For Suspension
Route of AdministrationORAL
Marketing Start Date2011-03-10
Marketing CategoryANDA / ANDA
Application NumberANDA065419
Labeler NamePreferred Pharmaceuticals, Inc.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength200 mg/5mL
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 68788-9046-3

30 mL in 1 BOTTLE (68788-9046-3)
Marketing Start Date2011-03-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68788-9046-1 [68788904601]

Azithromycin POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065419
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-10
Marketing End Date2013-05-22

NDC 68788-9046-2 [68788904602]

Azithromycin POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065419
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-10
Marketing End Date2013-05-22

NDC 68788-9046-3 [68788904603]

Azithromycin POWDER, FOR SUSPENSION
Marketing CategoryANDA
Application NumberANDA065419
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2011-03-10
Marketing End Date2019-06-06

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE200 mg/5mL

OpenFDA Data

SPL SET ID:51835dc6-68c7-44b0-980c-f9b38b8d7203
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308459
  • 141963

    • 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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