NDC 70518-0734

Azithromycin Dihydrate

Azithromycin

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

Product ID70518-0734_592b8f2b-9951-95b6-e053-2991aa0a4a65
NDC70518-0734
Product TypeHuman Prescription Drug
Proprietary NameAzithromycin Dihydrate
Generic NameAzithromycin
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-09-14
Marketing CategoryANDA / ANDA
Application NumberANDA065507
Labeler NameREMEDYREPACK INC.
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength250 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 70518-0734-0

4 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-0734-0)
Marketing Start Date2017-09-14
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0734-0 [70518073400]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA065507
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-14
Marketing End Date2020-05-04
Inactivation Date2020-01-31
Reactivation Date2020-05-12

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE250 mg/1

OpenFDA Data

SPL SET ID:96edc050-85bc-4ea7-9acc-df19f993b80d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308460
  • Pharmacological Class

    • 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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