NDC 25682-016

STRENSIQ

Asfotase Alfa

STRENSIQ is a Subcutaneous Solution in the Human Prescription Drug category. It is labeled and distributed by Alexion Pharmaceuticals, Inc.. The primary component is Asfotase Alfa.

Product ID25682-016_09d53de9-6c11-4f9f-9807-9141f9b7a91d
NDC25682-016
Product TypeHuman Prescription Drug
Proprietary NameSTRENSIQ
Generic NameAsfotase Alfa
Dosage FormSolution
Route of AdministrationSUBCUTANEOUS
Marketing Start Date2015-10-23
Marketing CategoryBLA / BLA
Application NumberBLA125513
Labeler NameAlexion Pharmaceuticals, Inc.
Substance NameASFOTASE ALFA
Active Ingredient Strength40 mg/mL
Pharm ClassesAlkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 25682-016-12

12 VIAL in 1 CARTON (25682-016-12) > 1 mL in 1 VIAL (25682-016-01)
Marketing Start Date2015-10-23
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 25682-016-01 [25682001601]

STRENSIQ SOLUTION
Marketing CategoryBLA
Application NumberBLA125513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-23

NDC 25682-016-12 [25682001612]

STRENSIQ SOLUTION
Marketing CategoryBLA
Application NumberBLA125513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-10-23

Drug Details

Active Ingredients

IngredientStrength
ASFOTASE ALFA40 mg/mL

OpenFDA Data

SPL SET ID:3387574f-5eaa-4501-a71d-4cbfbd563031
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1720263
  • 1720280
  • 1720278
  • 1720276
  • 1720268
  • 1720275
  • 1720272
  • 1720271
  • Pharmacological Class

    • Tissue-nonspecific Alkaline Phosphatase [EPC]
    • Alkaline Phosphatase [CS]
    • Tissue-nonspecific Alkaline Phosphatase [EPC]
    • Alkaline Phosphatase [CS]

    NDC Crossover Matching brand name "STRENSIQ" or generic name "Asfotase Alfa"

    NDCBrand NameGeneric Name
    25682-010STRENSIQASFOTASE ALFA
    25682-013STRENSIQASFOTASE ALFA
    25682-016STRENSIQASFOTASE ALFA
    25682-019STRENSIQASFOTASE ALFA

    Trademark Results [STRENSIQ]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    STRENSIQ
    STRENSIQ
    86105490 4874927 Live/Registered
    Alexion Pharmaceuticals, Inc.
    2013-10-30

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