NDC 51672-4200

Azithromycin

Azithromycin Monohydrate

Azithromycin is a Oral Suspension in the Human Prescription Drug category. It is labeled and distributed by Taro Pharmaceuticals U.s.a., Inc.. The primary component is Azithromycin Monohydrate.

Product ID51672-4200_30b09990-10ca-4452-920b-c1d1dc830120
NDC51672-4200
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin Monohydrate
Dosage FormSuspension
Route of AdministrationORAL
Marketing Start Date2019-12-11
Marketing CategoryANDA / ANDA
Application NumberANDA211521
Labeler NameTaro Pharmaceuticals U.S.A., Inc.
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength200 mg/5mL
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51672-4200-3

1 BOTTLE in 1 CARTON (51672-4200-3) > 30 mL in 1 BOTTLE
Marketing Start Date2019-12-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51672-4200-5 [51672420005]

Azithromycin SUSPENSION
Marketing CategoryANDA
Application NumberANDA211521
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-11

NDC 51672-4200-7 [51672420007]

Azithromycin SUSPENSION
Marketing CategoryANDA
Application NumberANDA211521
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-11

NDC 51672-4200-3 [51672420003]

Azithromycin SUSPENSION
Marketing CategoryANDA
Application NumberANDA211521
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-12-11

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE200 mg/5mL

OpenFDA Data

SPL SET ID:071e71b8-bb53-4075-9bda-2ec48affa018
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 141963

    • Pharmacological Class

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.