NDC 51224-122

Azithromycin Dihydrate

Azithromycin Dihydrate

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

Product ID51224-122_59709c0d-546e-4bab-ad9e-9eba468e1e8f
NDC51224-122
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin Dihydrate
Generic NameAzithromycin Dihydrate
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2019-07-01
Marketing CategoryANDA / ANDA
Application NumberANDA208249
Labeler NameTAGI Pharma, Inc.
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 51224-122-03

1 BLISTER PACK in 1 CARTON (51224-122-03) > 3 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2019-07-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 51224-122-30 [51224012230]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208249
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-01

NDC 51224-122-03 [51224012203]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208249
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-01

NDC 51224-122-09 [51224012209]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208249
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-07-01

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

OpenFDA Data

SPL SET ID:41e2163b-af61-4323-8b9c-2d44fc122fd9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656
  • 749780
    • UPC Code
  • 0351224122093

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Azithromycin Dihydrate" or generic name "Azithromycin Dihydrate"

    NDCBrand NameGeneric Name
    68788-9521Azithromycin DihydrateAzithromycin Dihydrate
    68788-9529Azithromycin DihydrateAzithromycin Dihydrate
    70518-0734Azithromycin DihydrateAzithromycin Dihydrate
    70882-107Azithromycin DihydrateAzithromycin Dihydrate
    70882-118Azithromycin DihydrateAzithromycin Dihydrate
    0904-6405Azithromycin DihydrateAzithromycin Dihydrate
    45865-641Azithromycin DihydrateAzithromycin Dihydrate
    50090-1655Azithromycin DihydrateAzithromycin Dihydrate
    50090-2334azithromycin dihydrateazithromycin dihydrate
    50268-104Azithromycin DihydrateAzithromycin Dihydrate
    50436-2852Azithromycin DihydrateAzithromycin Dihydrate
    53002-2221Azithromycin DihydrateAzithromycin Dihydrate
    55154-4333Azithromycin DihydrateAzithromycin Dihydrate
    61919-362AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATE
    63187-284Azithromycin DihydrateAzithromycin Dihydrate
    51224-122Azithromycin DihydrateAzithromycin Dihydrate
    51224-022Azithromycin DihydrateAzithromycin Dihydrate
    51224-222Azithromycin dihydrateAzithromycin dihydrate
    50090-4527Azithromycin DihydrateAzithromycin Dihydrate
    50090-4528Azithromycin DihydrateAzithromycin Dihydrate
    50090-4601Azithromycin DihydrateAzithromycin Dihydrate
    50090-4700Azithromycin DihydrateAzithromycin Dihydrate
    0527-2750Azithromycin DihydrateAzithromycin Dihydrate
    71205-430Azithromycin DihydrateAzithromycin Dihydrate
    72789-063Azithromycin DihydrateAzithromycin Dihydrate
    72789-066Azithromycin DihydrateAzithromycin Dihydrate
    72789-081Azithromycin DihydrateAzithromycin Dihydrate
    55700-859Azithromycin DihydrateAzithromycin Dihydrate
    72189-090AZITHROMYCIN DIHYDRATEAZITHROMYCIN DIHYDRATE
    71205-491Azithromycin DihydrateAzithromycin Dihydrate
    50268-076Azithromycin DihydrateAzithromycin Dihydrate
    53002-7221Azithromycin DihydrateAzithromycin Dihydrate
    50268-074Azithromycin DihydrateAzithromycin Dihydrate
    76420-046Azithromycin DihydrateAzithromycin Dihydrate
    53002-0474Azithromycin DihydrateAzithromycin Dihydrate
    0069-0400Zithromaxazithromycin dihydrate
    0069-3051ZITHROMAXAZITHROMYCIN DIHYDRATE
    0069-3060Zithromaxazithromycin dihydrate
    0069-3070Zithromaxazithromycin dihydrate
    0069-3080ZITHROMAXAZITHROMYCIN DIHYDRATE
    0069-3110Zithromaxazithromycin dihydrate
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.