NDC 0527-2395

azithromycin

Azithromycin Monohydrate

azithromycin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Lannett Company, Inc.. The primary component is Azithromycin Monohydrate.

Product ID0527-2395_a2b0cedf-87ae-d350-e053-2a95a90a16c4
NDC0527-2395
Product TypeHuman Prescription Drug
Proprietary Nameazithromycin
Generic NameAzithromycin Monohydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-04
Marketing CategoryANDA / ANDA
Application NumberANDA209044
Labeler NameLannett Company, Inc.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0527-2395-17

3 TABLET, FILM COATED in 1 BLISTER PACK (0527-2395-17)
Marketing Start Date2020-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0527-2395-32 [00527239532]

azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209044
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-02-11

NDC 0527-2395-72 [00527239572]

azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-11

NDC 0527-2395-17 [00527239517]

azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209044
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-02-11

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/1

OpenFDA Data

SPL SET ID:a2b0c06b-e93d-f5aa-e053-2995a90ac9aa
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656
  • 749783
  • 308460
  • 749780

    • 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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