NDC 0904-6405

Azithromycin Dihydrate

Azithromycin

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

Product ID0904-6405_7872b739-69a6-4b59-8ef5-a3a5f82e7e8c
NDC0904-6405
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin Dihydrate
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2011-07-18
Marketing CategoryANDA / ANDA
Application NumberANDA065507
Labeler NameMajor Pharmaceuticals
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0904-6405-06

50 BLISTER PACK in 1 CARTON (0904-6405-06) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2011-07-18
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0904-6405-06 [00904640506]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065507
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-18

NDC 0904-6405-61 [00904640561]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065507
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2011-07-18

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:9882bbca-dc10-43a8-8e20-472fb63cfa8d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308460
  • Pharmacological Class

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

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

    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

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