NDC 67457-794

Zoledronic Acid

Zoledronic Acid

Zoledronic Acid is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Zoledronic Acid.

Product ID67457-794_80006f10-85a3-4390-b5dc-3b2097134f3d
NDC67457-794
Product TypeHuman Prescription Drug
Proprietary NameZoledronic Acid
Generic NameZoledronic Acid
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2018-06-05
Marketing CategoryANDA / ANDA
Application NumberANDA205254
Labeler NameMylan Institutional LLC
Substance NameZOLEDRONIC ACID
Active Ingredient Strength5 mg/100mL
Pharm ClassesDiphosphonates [CS],Bisphosphonate [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-794-10

1 BAG in 1 POUCH (67457-794-10) > 100 mL in 1 BAG
Marketing Start Date2018-06-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-794-10 [67457079410]

Zoledronic Acid INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA205254
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-06-05

Drug Details

Active Ingredients

IngredientStrength
ZOLEDRONIC ACID5 mg/100mL

OpenFDA Data

SPL SET ID:80006f10-85a3-4390-b5dc-3b2097134f3d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 705824
  • Pharmacological Class

    • Diphosphonates [CS]
    • Bisphosphonate [EPC]
    • Diphosphonates [CS]
    • Bisphosphonate [EPC]

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

    NDCBrand NameGeneric Name
    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
    68001-366Zoledronic AcidZoledronic Acid
    68083-116Zoledronic AcidZoledronic Acid
    68083-142Zoledronic AcidZoledronic Acid
    68083-135Zoledronic AcidZoledronic Acid
    69097-399ZOLEDRONIC ACIDZOLEDRONIC ACID
    70860-210Zoledronic AcidZoledronic Acid
    25021-830zoledronic acidzoledronic acid
    42023-151Zoledronic AcidZoledronic Acid
    42023-167Zoledronic AcidZoledronic Acid
    42023-163Zoledronic AcidZoledronic Acid
    43598-331Zoledronic AcidZoledronic Acid
    43598-330Zoledronic AcidZoledronic Acid
    43598-255Zoledronic acidZoledronic acid
    45963-440Zoledronic AcidZoledronic Acid
    51991-065Zoledronic AcidZoledronic Acid
    51991-064Zoledronic AcidZoledronic Acid
    54288-100ZOLEDRONIC ACIDZOLEDRONIC ACID
    55150-283Zoledronic AcidZoledronic Acid
    55111-685Zoledronic AcidZoledronic Acid
    55111-688Zoledronic AcidZoledronic Acid
    55150-266Zoledronic AcidZoledronic Acid
    55648-185Zoledronic AcidZoledronic Acid
    55648-186Zoledronic AcidZoledronic Acid
    60505-6110Zoledronic AcidZoledronic Acid
    63323-966Zoledronic AcidZoledronic Acid
    63323-961Zoledronic AcidZoledronic Acid
    64679-186Zoledronic AcidZoledronic Acid
    64679-185Zoledronic AcidZoledronic Acid
    67457-794Zoledronic AcidZoledronic Acid
    67457-390Zoledronic acidZoledronic acid
    67457-619Zoledronic AcidZoledronic Acid
    0078-0435Reclastzoledronic acid
    0078-0387Zometazoledronic acid
    0078-0590Zometazoledronic acid

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.