NDC 71205-158

Azithromycin

Azithromycin

Azithromycin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Proficient Rx Lp. The primary component is Azithromycin Dihydrate.

Product ID71205-158_3a6724c4-9e52-4de5-867b-00c4ff6d17b6
NDC71205-158
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2018-07-05
Marketing CategoryANDA / ANDA
Application NumberANDA207370
Labeler NameProficient Rx LP
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71205-158-03

3 TABLET, FILM COATED in 1 BOTTLE (71205-158-03)
Marketing Start Date2018-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71205-158-03 [71205015803]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

NDC 71205-158-66 [71205015866]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-12-11

NDC 71205-158-06 [71205015806]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-11-01

NDC 71205-158-30 [71205015830]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-11-01

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:cb40f4cf-15ae-47ab-8e0a-979467fa0d9e
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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