NDC 62756-218

IBANDRONATE SODIUM

Ibandronate Sodium

IBANDRONATE SODIUM is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Sun Pharmaceutical Industries, Inc.. The primary component is Ibandronate Sodium.

Product ID62756-218_0f625030-ac6c-48de-ad3d-ea15115dc2b3
NDC62756-218
Product TypeHuman Prescription Drug
Proprietary NameIBANDRONATE SODIUM
Generic NameIbandronate Sodium
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-02-15
Marketing CategoryANDA / ANDA
Application NumberANDA090853
Labeler NameSun Pharmaceutical Industries, Inc.
Substance NameIBANDRONATE SODIUM
Active Ingredient Strength3 mg/3mL
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 62756-218-40

1 VIAL, SINGLE-DOSE in 1 CARTON (62756-218-40) > 3 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2014-02-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62756-218-40 [62756021840]

IBANDRONATE SODIUM INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA090853
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-02-15
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
IBANDRONATE SODIUM3 mg/3mL

OpenFDA Data

SPL SET ID:be514be6-727a-4d6c-993b-52144f8e6de8
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904955
  • Pharmacological Class

    • 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

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