NDC 0078-0387

Zometa

Zoledronic Acid

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

Product ID0078-0387_017ed248-e250-4cd7-ae15-5efeb1aeee3d
NDC0078-0387
Product TypeHuman Prescription Drug
Proprietary NameZometa
Generic NameZoledronic Acid
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2001-08-20
Marketing End Date2020-11-30
Marketing CategoryNDA / NDA
Application NumberNDA021223
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameZOLEDRONIC ACID
Active Ingredient Strength4 mg/5mL
Pharm ClassesDiphosphonates [CS],Bisphosphonate [EPC]
NDC Exclude FlagN

Packaging

NDC 0078-0387-25

1 VIAL in 1 CARTON (0078-0387-25) > 5 mL in 1 VIAL
Marketing Start Date2001-08-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0387-25 [00078038725]

Zometa INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryNDA
Application NumberNDA021223
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2001-08-20
Marketing End Date2020-11-30

Drug Details

Active Ingredients

IngredientStrength
ZOLEDRONIC ACID4 mg/5mL

OpenFDA Data

SPL SET ID:f0cdfa57-95e5-416b-bc2f-cde2491c2fd0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351945
  • 351114
  • 1114087
  • 1114085

    • Pharmacological Class

    • Diphosphonates [CS]
    • Bisphosphonate [EPC]

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

    NDCBrand NameGeneric Name
    0078-0387Zometazoledronic acid
    0078-0590Zometazoledronic acid
    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

    Trademark Results [Zometa]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ZOMETA
    ZOMETA
    75411654 2393885 Live/Registered
    NOVARTIS AG
    1997-12-29
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