NDC 72789-066

Azithromycin Dihydrate

Azithromycin Dihydrate

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

Product ID72789-066_a18844ba-b694-9134-e053-2a95a90a136f
NDC72789-066
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 NamePD-Rx Pharmaceuticals, Inc.
Substance NameAZITHROMYCIN DIHYDRATE
Active Ingredient Strength500 mg/1
Pharm ClassesMacrolide Antimicrobial [EPC],Macrolides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 72789-066-02

2 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-066-02)
Marketing Start Date2020-03-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 72789-066-07 [72789006607]

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

NDC 72789-066-02 [72789006602]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208249
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-23

NDC 72789-066-79 [72789006679]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208249
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-30

NDC 72789-066-03 [72789006603]

Azithromycin Dihydrate TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA208249
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2020-04-20

Drug Details

Active Ingredients

IngredientStrength
AZITHROMYCIN DIHYDRATE500 mg/1

OpenFDA Data

SPL SET ID:d07bb450-f0ac-4faa-8289-9d4e45bb0a88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 248656

    • Pharmacological Class

    • 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
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