NDC 0178-0101

Binosto

Alendronate Sodium

Binosto is a Oral Tablet, Effervescent in the Human Prescription Drug category. It is labeled and distributed by Mission Pharmacal Company. The primary component is Alendronate Sodium.

Product ID0178-0101_78d320a1-3ec7-1a45-e053-2a91aa0a1f9b
NDC0178-0101
Product TypeHuman Prescription Drug
Proprietary NameBinosto
Generic NameAlendronate Sodium
Dosage FormTablet, Effervescent
Route of AdministrationORAL
Marketing Start Date2012-09-03
Marketing CategoryNDA / NDA
Application NumberNDA202344
Labeler NameMission Pharmacal Company
Substance NameALENDRONATE SODIUM
Active Ingredient Strength70 mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0178-0101-02

4 TABLET, EFFERVESCENT in 1 CARTON (0178-0101-02)
Marketing Start Date2012-09-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0178-0101-01 [00178010101]

Binosto TABLET, EFFERVESCENT
Marketing CategoryNDA
Application NumberNDA202344
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-03
Inactivation Date2020-01-31

NDC 0178-0101-03 [00178010103]

Binosto TABLET, EFFERVESCENT
Marketing CategoryNDA
Application NumberNDA202344
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-09-03
Marketing End Date2016-11-07

NDC 0178-0101-02 [00178010102]

Binosto TABLET, EFFERVESCENT
Marketing CategoryNDA
Application NumberNDA202344
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-09-03
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ALENDRONATE SODIUM70 mg/1

OpenFDA Data

SPL SET ID:ad670460-141b-e481-f713-7aed9485de8d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1248083
  • 1248077

    • Pharmacological Class

    • Bisphosphonate [EPC]
    • Diphosphonates [CS]

    NDC Crossover Matching brand name "Binosto" or generic name "Alendronate Sodium"

    NDCBrand NameGeneric Name
    0178-0101Binostoalendronate sodium
    17139-400Binostoalendronate sodium
    10135-696AlendronateAlendronate Sodium
    10135-697AlendronateAlendronate Sodium
    0054-0282Alendronate SodiumAlendronate Sodium
    0115-1676Alendronate SodiumAlendronate Sodium
    0115-1678Alendronate SodiumAlendronate Sodium
    0115-1679Alendronate SodiumAlendronate Sodium
    0115-1680Alendronate SodiumAlendronate Sodium
    0115-1681Alendronate SodiumAlendronate Sodium
    0378-3566Alendronate Sodiumalendronate sodium
    16252-599alendronate sodiumalendronate sodium
    16252-601alendronate sodiumalendronate sodium
    16714-631Alendronate SodiumAlendronate Sodium
    16714-632Alendronate SodiumAlendronate Sodium
    16714-633Alendronate SodiumAlendronate Sodium
    21695-901Alendronate Sodiumalendronate sodium
    21695-902Alendronate Sodiumalendronate sodium
    33261-554Alendronate SodiumAlendronate Sodium
    33261-820Alendronate SodiumAlendronate Sodium
    0006-0031FOSAMAXalendronate sodium

    Trademark Results [Binosto]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    BINOSTO
    BINOSTO
    85173657 4242545 Live/Registered
    EFFRX PHARMACEUTICALS S.A.
    2010-11-10
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