NDC 25021-801

zoledronic acid

Zoledronic Acid

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

Product ID25021-801_4c05bd56-57ca-4426-9502-d510eb4d8fc7
NDC25021-801
Product TypeHuman Prescription Drug
Proprietary Namezoledronic acid
Generic NameZoledronic Acid
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-12-29
Marketing CategoryANDA / ANDA
Application NumberANDA091493
Labeler NameSagent Pharmaceuticals
Substance NameZOLEDRONIC ACID
Active Ingredient Strength1 mg/mL
Pharm ClassesDiphosphonates [CS],Bisphosphonate [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 25021-801-66

1 VIAL in 1 CARTON (25021-801-66) > 5 mL in 1 VIAL
Marketing Start Date2014-12-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25021-801-67 [25021080167]

zoledronic acid INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA091493
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-09-01
Marketing End Date2018-10-31

NDC 25021-801-66 [25021080166]

zoledronic acid INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA091493
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-12-29

Drug Details

Active Ingredients

IngredientStrength
ZOLEDRONIC ACID.8 mg/mL

OpenFDA Data

SPL SET ID:6b056e07-f432-4523-af5f-b3cc141a3a0d
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

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