NDC 54348-857

Azithromycin

Azithromycin Monohydrate

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

Product ID54348-857_8f9eba2f-59e0-7229-e053-2995a90aec50
NDC54348-857
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin Monohydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-10
Marketing CategoryANDA / ANDA
Application NumberANDA065225
Labeler NamePharmPak, Inc.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 54348-857-00

1 BOTTLE in 1 BOX (54348-857-00) > 1 TABLET, FILM COATED in 1 BOTTLE
Marketing Start Date2019-07-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 54348-857-01 [54348085701]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-857-00 [54348085700]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

NDC 54348-857-02 [54348085702]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065225
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-07-10

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE500 mg/1

Pharmacological Class

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

NDC Crossover Matching brand name "Azithromycin" or generic name "Azithromycin Monohydrate"

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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