NDC 0078-0435

Reclast

Zoledronic Acid

Reclast is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Zoledronic Acid.

Product ID0078-0435_11f43267-ad74-4c5e-b86a-3c89d7e83436
NDC0078-0435
Product TypeHuman Prescription Drug
Proprietary NameReclast
Generic NameZoledronic Acid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2007-04-01
Marketing CategoryNDA / NDA
Application NumberNDA021817
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameZOLEDRONIC ACID
Active Ingredient Strength5 mg/100mL
Pharm ClassesDiphosphonates [CS],Bisphosphonate [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0078-0435-61

100 mL in 1 BOTTLE (0078-0435-61)
Marketing Start Date2007-04-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0435-61 [00078043561]

Reclast INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA021817
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2007-04-01

Drug Details

Active Ingredients

IngredientStrength
ZOLEDRONIC ACID5 mg/100mL

OpenFDA Data

SPL SET ID:3c79ff9c-a6f4-405d-b19c-7e473a61dedc
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 705824
  • 705875

    • Pharmacological Class

    • Diphosphonates [CS]
    • Bisphosphonate [EPC]

    NDC Crossover Matching brand name "Reclast" or generic name "Zoledronic Acid"

    NDCBrand NameGeneric Name
    0078-0435Reclastzoledronic acid
    0143-9642Zoledronic Acidzoledronic acid
    0409-4215ZOLEDRONIC ACIDZOLEDRONIC ACID
    0409-4228ZOLEDRONIC ACIDZOLEDRONIC ACID
    0409-4229Zoledronic AcidZOLEDRONIC ACID
    16714-815Zoledronic Acidzoledronic Acid
    16729-242Zoledronic acidzoledronic acid
    17478-324Zoledronic AcidZoledronic Acid
    17478-327Zoledronic AcidZoledronic Acid
    23155-170Zoledronic acidZoledronic acid
    23155-186Zoledronic acidZoledronic acid
    23155-525Zoledronic acidZoledronic acid
    25021-801zoledronic acidzoledronic acid
    25021-826zoledronic acidzoledronic acid
    0078-0387Zometazoledronic acid
    0078-0590Zometazoledronic acid

    Trademark Results [Reclast]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    RECLAST
    RECLAST
    78152398 2895114 Live/Registered
    Novartis AG
    2002-08-08
    RECLAST
    RECLAST
    77584034 3606037 Live/Registered
    Novartis AG
    2008-10-02
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