NDC 55648-964

AZITHROMYCIN

Azithromycin

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

Product ID55648-964_e25928bc-ff72-4b62-b372-c50a7a3b9960
NDC55648-964
Product TypeHuman Prescription Drug
Proprietary NameAZITHROMYCIN
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2008-02-11
Marketing CategoryANDA / ANDA
Application NumberANDA065405
Labeler NameWOCKHARDT LIMITED
Substance NameAZITHROMYCIN ANHYDROUS
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [Chemical/Ingredient]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 55648-964-05

3 BLISTER PACK in 1 CARTON (55648-964-05) > 3 TABLET, FILM COATED in 1 BLISTER PACK (55648-964-03)
Marketing Start Date2008-02-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 55648-964-06 [55648096406]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-02-11
Inactivation Date2019-10-29

NDC 55648-964-02 [55648096402]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-02-11
Inactivation Date2019-10-29

NDC 55648-964-01 [55648096401]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-02-11
Inactivation Date2019-10-29

NDC 55648-964-07 [55648096407]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-02-11
Inactivation Date2019-10-29

NDC 55648-964-05 [55648096405]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-02-11
Inactivation Date2019-10-29

NDC 55648-964-03 [55648096403]

AZITHROMYCIN TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2008-02-11

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN ANHYDROUS500 mg/1

OpenFDA Data

SPL SET ID:a7bf9202-9590-49c8-bde1-78517e60850f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656
  • 308460
    • UPC Code
  • 0364679964071
  • 0364679961018

    • Pharmacological Class

    • Macrolide Antimicrobial [EPC]
    • Macrolides [Chemical/Ingredient]

    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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