NDC 16571-695

Azithromycin

Azithromycin

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

Product ID16571-695_2345cc0e-4f53-42a2-b7e8-d500c316a031
NDC16571-695
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 NameRising Pharma Holdings, Inc.
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 16571-695-03

30 TABLET, FILM COATED in 1 BOTTLE (16571-695-03)
Marketing Start Date2018-07-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16571-695-03 [16571069503]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-05

NDC 16571-695-16 [16571069516]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-05

NDC 16571-695-05 [16571069505]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-05

NDC 16571-695-01 [16571069501]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-05

NDC 16571-695-81 [16571069581]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-05

NDC 16571-695-50 [16571069550]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA207370
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-05

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:c3c049cc-27b0-461d-96d2-345717e3ca18
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656
  • 749783
  • 308460
  • 749780
    • UPC Code
  • 0316571695034
  • 0316571696031

    • 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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