NDC 70518-0225

Azithromycin

Azithromycin

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

Product ID70518-0225_4f1ceb2a-dfba-1cdf-e054-00144ff8d46c
NDC70518-0225
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-02-16
Marketing CategoryANDA / ANDA
Application NumberANDA065193
Labeler NameREMEDYREPACK INC.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0225-0

2 TABLET, FILM COATED in 1 BOX, UNIT-DOSE (70518-0225-0)
Marketing Start Date2017-02-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0225-0 [70518022500]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-16
Marketing End Date2018-02-16
Inactivation Date2020-01-31
Reactivation Date2020-03-02

NDC 70518-0225-1 [70518022501]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-03-24
Marketing End Date2018-11-09
Inactivation Date2020-01-31
Reactivation Date2020-03-02

NDC 70518-0225-2 [70518022502]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065193
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-02-26
Marketing End Date2018-04-19
Inactivation Date2020-01-31
Reactivation Date2020-03-02

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/1

OpenFDA Data

SPL SET ID:77a86c83-4e65-433f-9c74-d3e0b11f67af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656

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