NDC 71610-001

Azithromycin

Azithromycin

Azithromycin is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aphena Pharma Solutions - Tennessee, Llc. The primary component is Azithromycin Monohydrate.

Product ID71610-001_888edaa1-a8bd-43da-aa09-6eb5ee7fe515
NDC71610-001
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-03-02
Marketing CategoryANDA / ANDA
Application NumberANDA065211
Labeler NameAphena Pharma Solutions - Tennessee, LLC
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 71610-001-06

6 TABLET, FILM COATED in 1 BOTTLE (71610-001-06)
Marketing Start Date2017-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71610-001-87 [71610000187]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-08-23

NDC 71610-001-06 [71610000106]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-31

NDC 71610-001-30 [71610000130]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-07-31

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:ec761c30-18cf-49b1-a444-69cd28a9b960
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 749783
  • 308460
  • Pharmacological Class

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