NDC 0409-4215

ZOLEDRONIC ACID

Zoledronic Acid

ZOLEDRONIC ACID is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Hospira, Inc.. The primary component is Zoledronic Acid.

Product ID0409-4215_012b15e6-d638-400a-96b9-44f6e9741baf
NDC0409-4215
Product TypeHuman Prescription Drug
Proprietary NameZOLEDRONIC ACID
Generic NameZoledronic Acid
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-10-19
Marketing CategoryANDA / ANDA
Application NumberANDA090621
Labeler NameHospira, Inc.
Substance NameZOLEDRONIC ACID
Active Ingredient Strength4 mg/5mL
Pharm ClassesBisphosphonate [EPC], Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0409-4215-01

1 VIAL, PLASTIC in 1 CARTON (0409-4215-01) > 5 mL in 1 VIAL, PLASTIC
Marketing Start Date2017-10-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0409-4215-05 [00409421505]

ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA090621
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-03-18

NDC 0409-4215-01 [00409421501]

ZOLEDRONIC ACID INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA090621
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2017-10-19

Drug Details

Active Ingredients

IngredientStrength
ZOLEDRONIC ACID4 mg/5mL

OpenFDA Data

SPL SET ID:6f5c1c1d-00dc-4ac4-84ae-0804ab257985
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351114
  • Pharmacological Class

    • 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.