NDC 68083-116

Zoledronic Acid

Zoledronic Acid

Zoledronic Acid is a Intravenous Injection, Solution, Concentrate in the Human Prescription Drug category. It is labeled and distributed by Gland Pharma Limited. The primary component is Zoledronic Acid.

Product ID68083-116_26703f2f-0b97-4699-9403-625cc39c1f2c
NDC68083-116
Product TypeHuman Prescription Drug
Proprietary NameZoledronic Acid
Generic NameZoledronic Acid
Dosage FormInjection, Solution, Concentrate
Route of AdministrationINTRAVENOUS
Marketing Start Date2013-09-20
Marketing CategoryANDA / ANDA
Application NumberANDA202930
Labeler NameGland Pharma Limited
Substance NameZOLEDRONIC ACID
Active Ingredient Strength4 mg/5mL
Pharm ClassesDiphosphonates [CS],Bisphosphonate [EPC]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68083-116-01

1 VIAL in 1 CARTON (68083-116-01) > 5 mL in 1 VIAL
Marketing Start Date2013-09-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68083-116-01 [68083011601]

Zoledronic Acid INJECTION, SOLUTION, CONCENTRATE
Marketing CategoryANDA
Application NumberANDA202930
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2013-09-20

Drug Details

Active Ingredients

IngredientStrength
ZOLEDRONIC ACID4 mg/5mL

OpenFDA Data

SPL SET ID:7a5e8962-7c4b-40bb-ad69-0c3edb0338af
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351114
  • 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.