NDC 0781-8089

Azithromycin

Azithromycin

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

Product ID0781-8089_116f172e-5a30-416f-9be0-f62adcc94701
NDC0781-8089
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2005-11-14
Marketing CategoryANDA / ANDA
Application NumberANDA065211
Labeler NameSandoz Inc
Substance NameAZITHROMYCIN MONOHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0781-8089-26

6 DOSE PACK in 1 CARTON (0781-8089-26) > 1 TABLET, FILM COATED in 1 DOSE PACK
Marketing Start Date2019-02-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-8089-31 [00781808931]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-14

NDC 0781-8089-69 [00781808969]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-14

NDC 0781-8089-26 [00781808926]

Azithromycin TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065211
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-14

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN MONOHYDRATE250 mg/1

Pharmacological Class

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