NDC 46708-253

AZITHROMYCIN

Azithromycin

AZITHROMYCIN is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Alembic Pharmaceuticals Limited. The primary component is Azithromycin Dihydrate.

Product ID46708-253_5dca5a11-3c02-4a51-a35d-f91f37b8e00c
NDC46708-253
Product TypeHuman Prescription Drug
Proprietary NameAZITHROMYCIN
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2020-01-28
Marketing CategoryANDA / ANDA
Application NumberANDA211793
Labeler NameAlembic Pharmaceuticals Limited
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength600 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 46708-253-10

100 BLISTER PACK in 1 CARTON (46708-253-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2020-01-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 46708-253-30 [46708025330]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211793
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-28

NDC 46708-253-10 [46708025310]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA211793
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-01-28

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE600 mg/1

OpenFDA Data

SPL SET ID:5dca5a11-3c02-4a51-a35d-f91f37b8e00c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 204844
    • UPC Code
  • 0346708253301

    • 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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