NDC 67457-524

ibandronate sodium

Ibandronate Sodium

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

Product ID67457-524_4b6cecb5-336c-4909-8cba-823a4a62e775
NDC67457-524
Product TypeHuman Prescription Drug
Proprietary Nameibandronate sodium
Generic NameIbandronate Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-09-02
Marketing CategoryANDA / ANDA
Application NumberANDA202671
Labeler NameMylan Institutional LLC
Substance NameIBANDRONATE SODIUM
Active Ingredient Strength3 mg/3mL
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-524-33

1 SYRINGE, GLASS in 1 CARTON (67457-524-33) > 3 mL in 1 SYRINGE, GLASS
Marketing Start Date2014-09-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-524-33 [67457052433]

ibandronate sodium INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA202671
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-09-02

Drug Details

Active Ingredients

IngredientStrength
IBANDRONATE SODIUM3 mg/3mL

OpenFDA Data

SPL SET ID:a70566e1-cbe5-472a-85ae-08a14117552a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904952

    • Pharmacological Class

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

    NDC Crossover Matching brand name "ibandronate sodium" or generic name "Ibandronate Sodium"

    NDCBrand NameGeneric Name
    23155-162Ibandronate sodiumIbandronate sodium
    25021-827ibandronate sodiumibandronate sodium
    33342-150IBANDRONATE SODIUMIBANDRONATE SODIUM
    47781-103IBANDRONATE SODIUMIBANDRONATE SODIUM
    51224-008IBANDRONATE SODIUMIbandronate Sodium
    55111-575Ibandronate sodiumIbandronate sodium
    55150-191Ibandronate SodiumIbandronate Sodium
    60429-643IBANDRONATE SODIUMIBANDRONATE SODIUM
    60505-2795IBANDRONATE SODIUMIBANDRONATE SODIUM
    60505-6097Ibandronate Sodiumibandronate sodium
    62756-218IBANDRONATE SODIUMIBANDRONATE SODIUM
    65862-237Ibandronate SodiumIbandronate Sodium
    67457-524ibandronate sodiumibandronate sodium
    0004-0186Bonivaibandronate sodium
    0004-0191Bonivaibandronate sodium
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