NDC 62980-964

Azithromycin

Azithromycin

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

Product ID62980-964_abb76e1d-a0c6-407b-b70c-1d5da87f4902
NDC62980-964
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 NameVivimed Labs Limited
Substance NameAZITHROMYCIN ANHYDROUS
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 62980-964-05

3 BLISTER PACK in 1 CARTON (62980-964-05) > 3 TABLET, FILM COATED in 1 BLISTER PACK (62980-964-03)
Marketing Start Date2015-07-28
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62980-964-05 [62980096405]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-28
Inactivation Date2020-01-31

NDC 62980-964-07 [62980096407]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-28
Inactivation Date2020-01-31

NDC 62980-964-03 [62980096403]

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

NDC 62980-964-01 [62980096401]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-28
Inactivation Date2020-01-31

NDC 62980-964-08 [62980096408]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-28
Inactivation Date2020-01-31

NDC 62980-964-09 [62980096409]

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

NDC 62980-964-02 [62980096402]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065405
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-28
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN ANHYDROUS500 mg/1

OpenFDA Data

SPL SET ID:f6edd3c1-4455-4f05-b554-49d59d442270
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656
  • 749783
  • 308460
  • 749780
    • UPC Code
  • 0364679964019
  • 0364679961018

    • 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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