NDC 10135-697

Alendronate

Alendronate Sodium

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

Product ID10135-697_76e6ead3-9532-4206-ad5f-a4a8a1eba934
NDC10135-697
Product TypeHuman Prescription Drug
Proprietary NameAlendronate
Generic NameAlendronate Sodium
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2020-03-01
Marketing CategoryANDA / ANDA
Application NumberANDA090258
Labeler NameMarlex Pharmaceuticals Inc
Substance NameALENDRONATE SODIUM
Active Ingredient Strength70 mg/1
Pharm ClassesBisphosphonate [EPC],Diphosphonates [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 10135-697-12

3 BLISTER PACK in 1 CARTON (10135-697-12) > 4 TABLET in 1 BLISTER PACK
Marketing Start Date2020-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-697-20 [10135069720]

Alendronate TABLET
Marketing CategoryANDA
Application NumberANDA090258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-01

NDC 10135-697-44 [10135069744]

Alendronate TABLET
Marketing CategoryANDA
Application NumberANDA090258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-01

NDC 10135-697-12 [10135069712]

Alendronate TABLET
Marketing CategoryANDA
Application NumberANDA090258
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2020-03-01

Drug Details

Active Ingredients

IngredientStrength
ALENDRONATE SODIUM70 mg/1

OpenFDA Data

SPL SET ID:c1e61b54-287f-47ed-9192-e3c98ecb2e06
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 904431
  • 904396

    • 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
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