NDC 0006-0031

FOSAMAX

Alendronate Sodium

FOSAMAX is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Alendronate Sodium.

Product ID0006-0031_37333f48-be6f-455d-878b-328bc51259c4
NDC0006-0031
Product TypeHuman Prescription Drug
Proprietary NameFOSAMAX
Generic NameAlendronate Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date1995-09-29
Marketing CategoryNDA / NDA
Application NumberNDA020560
Labeler NameMerck Sharp & Dohme Corp.
Substance NameALENDRONATE SODIUM
Active Ingredient Strength70 mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0006-0031-44

4 TABLET in 1 BLISTER PACK (0006-0031-44)
Marketing Start Date1995-09-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0006-0031-44 [00006003144]

FOSAMAX TABLET
Marketing CategoryNDA
Application NumberNDA020560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-09-29

NDC 0006-0031-21 [00006003121]

FOSAMAX TABLET
Marketing CategoryNDA
Application NumberNDA020560
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1995-09-29
Marketing End Date2012-07-09

NDC 0006-0031-01 [00006003101]

FOSAMAX TABLET
Marketing CategoryNDA
Application NumberNDA020560
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1995-09-29
Marketing End Date2012-07-09

Drug Details

Active Ingredients

IngredientStrength
ALENDRONATE SODIUM70 mg/1

OpenFDA Data

SPL SET ID:f2dcfb39-a7c2-4e39-9e35-852a3a74f947
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904431
  • 904433

    • Pharmacological Class

    • Bisphosphonate [EPC]
    • Diphosphonates [CS]

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

    NDCBrand NameGeneric Name
    0006-0031FOSAMAXalendronate 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
    0178-0101Binostoalendronate sodium
    17139-400Binostoalendronate sodium

    Trademark Results [FOSAMAX]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    FOSAMAX
    FOSAMAX
    76057522 2747775 Live/Registered
    MERCK SHARP & DOHME CORP.
    2000-05-26
    FOSAMAX
    FOSAMAX
    75044414 2073389 Dead/Cancelled
    MERCK & CO., Inc.
    1996-01-16
    FOSAMAX
    FOSAMAX
    75044413 2438692 Live/Registered
    MERCK SHARP & DOHME CORP.
    1996-01-16
    FOSAMAX
    FOSAMAX
    74132851 1710682 Live/Registered
    MERCK SHARP & DOHME CORP.
    1991-01-22
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.