NDC 48792-7871

azithromycin

Azithromycin Monohydrate

azithromycin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Sunshine Lake Pharma Co., Ltd.. The primary component is Azithromycin Monohydrate.

Product ID48792-7871_7d6b50cc-0b70-443d-e053-2991aa0ac583
NDC48792-7871
Product TypeHuman Prescription Drug
Proprietary Nameazithromycin
Generic NameAzithromycin Monohydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-12-20
Marketing CategoryANDA / ANDA
Application NumberANDA209043
Labeler NameSunshine Lake Pharma Co., Ltd.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength600 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 48792-7871-1

30 TABLET, FILM COATED in 1 BOTTLE (48792-7871-1)
Marketing Start Date2018-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 48792-7871-1 [48792787101]

azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA209043
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-12-20

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE600 mg/1

OpenFDA Data

SPL SET ID:7d6c37e2-0855-6f4d-e053-2a91aa0ae40d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204844
  • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [CS]
    • 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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.