NDC 33342-150

IBANDRONATE SODIUM

Ibandronate Sodium

IBANDRONATE SODIUM is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Macleods Pharmaceuticals Limited. The primary component is Ibandronate Sodium.

Product ID33342-150_5241a8d8-433b-45ba-b732-e0c496944b55
NDC33342-150
Product TypeHuman Prescription Drug
Proprietary NameIBANDRONATE SODIUM
Generic NameIbandronate Sodium
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2017-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA206887
Labeler NameMacleods Pharmaceuticals Limited
Substance NameIBANDRONATE SODIUM
Active Ingredient Strength150 mg/1
Pharm ClassesBisphosphonate [EPC], Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 33342-150-53

3 CARTON in 1 BOX (33342-150-53) > 1 BLISTER PACK in 1 CARTON (33342-150-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Start Date2018-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 33342-150-53 [33342015053]

IBANDRONATE SODIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206887
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-13

NDC 33342-150-52 [33342015052]

IBANDRONATE SODIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206887
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-11-01
Marketing End Date2018-06-12

NDC 33342-150-01 [33342015001]

IBANDRONATE SODIUM TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA206887
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-06-14

Drug Details

Active Ingredients

IngredientStrength
IBANDRONATE SODIUM150 mg/1

OpenFDA Data

SPL SET ID:a5741ef6-0599-4657-8cda-2902ded4f680
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904932

    • 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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