NDC 50090-2587

Alendronate

Alendronate Sodium

Alendronate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by A-s Medication Solutions. The primary component is Alendronate Sodium.

Product ID50090-2587_095dbeec-8bd5-4928-9351-df86a71041fd
NDC50090-2587
Product TypeHuman Prescription Drug
Proprietary NameAlendronate
Generic NameAlendronate Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2015-09-30
Marketing CategoryANDA / ANDA
Application NumberANDA090258
Labeler NameA-S Medication Solutions
Substance NameALENDRONATE SODIUM
Active Ingredient Strength70 mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 50090-2587-0

1 BLISTER PACK in 1 CARTON (50090-2587-0) > 4 TABLET in 1 BLISTER PACK
Marketing Start Date2016-11-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 50090-2587-1 [50090258701]

Alendronate TABLET
Marketing CategoryANDA
Application NumberANDA090258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-12-19
Marketing End Date2018-04-30

NDC 50090-2587-0 [50090258700]

Alendronate TABLET
Marketing CategoryANDA
Application NumberANDA090258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-11-02
Marketing End Date2018-04-30

Drug Details

Active Ingredients

IngredientStrength
ALENDRONATE SODIUM70 mg/1

OpenFDA Data

SPL SET ID:6f2240e5-6fd0-4a97-a0fe-ba6518394531
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904431
  • Pharmacological Class

    • Bisphosphonate [EPC]
    • Diphosphonates [CS]

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

    NDCBrand NameGeneric Name
    10135-696AlendronateAlendronate Sodium
    10135-697AlendronateAlendronate Sodium
    10135-718AlendronateAlendronate sodium tablet
    10135-719AlendronateAlendronate sodium tablet
    68071-4017AlendronateAlendronate
    68071-4072AlendronateAlendronate
    69543-131AlendronateAlendronate
    69543-130AlendronateAlendronate
    50090-2587AlendronateAlendronate
    50090-3593AlendronateAlendronate
    60723-205AlendronateAlendronate
    60723-207AlendronateAlendronate
    63629-7329AlendronateAlendronate
    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
    0178-0101Binostoalendronate sodium
    17139-400Binostoalendronate sodium
    0006-0031FOSAMAXalendronate sodium

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