NDC 70518-0108

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 ID70518-0108_81dc1187-69b9-04da-e053-2991aa0aa033
NDC70518-0108
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-01-06
Marketing CategoryANDA / ANDA
Application NumberANDA065211
Labeler NameREMEDYREPACK INC.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0108-1

6 TABLET, FILM COATED in 1 BLISTER PACK (70518-0108-1)
Marketing Start Date2017-01-09
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0108-1 [70518010801]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-09
Marketing End Date2018-08-30

NDC 70518-0108-2 [70518010802]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-09
Marketing End Date2018-09-13

NDC 70518-0108-0 [70518010800]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-01-06
Marketing End Date2018-07-07

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:aa0c11c8-0a63-4acb-b141-a92f3eaa6181
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308460

    • 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
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