NDC 68071-4017

Alendronate

Alendronate Sodium

Alendronate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Nucare Pharmaceuticals,inc.. The primary component is Alendronate Sodium.

Product ID68071-4017_55276dd1-a916-71dd-e054-00144ff8d46c
NDC68071-4017
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 NameNuCare Pharmaceuticals,Inc.
Substance NameALENDRONATE SODIUM
Active Ingredient Strength35 mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68071-4017-4

4 TABLET in 1 BOX (68071-4017-4)
Marketing Start Date2017-07-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68071-4017-4 [68071401704]

Alendronate TABLET
Marketing CategoryANDA
Application NumberANDA090258
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-25

Drug Details

Active Ingredients

IngredientStrength
ALENDRONATE SODIUM35 mg/1

OpenFDA Data

SPL SET ID:55276dd1-a915-71dd-e054-00144ff8d46c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904396
  • Pharmacological Class

    • Bisphosphonate [EPC]
    • Diphosphonates [CS]
    • 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

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