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 ID: 25682-016_09d53de9-6c11-4f9f-9807-9141f9b7a91d
• NDC: 25682-016
• Product Type: Human Prescription Drug
• Proprietary Name: STRENSIQ
• Generic Name: Asfotase Alfa
• Dosage Form: Solution
• Route of Administration: SUBCUTANEOUS
• Marketing Start Date: 2015-10-23
• Marketing Category: BLA / BLA
• Application Number: BLA125513
• Labeler Name: Alexion Pharmaceuticals, Inc.
• Substance Name: ASFOTASE ALFA
• Active Ingredient Strength: 40 mg/mL
• Pharm Classes: Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 25682-016-12

12 VIAL in 1 CARTON (25682-016-12) > 1 mL in 1 VIAL (25682-016-01)

• Marketing Start Date: 2015-10-23
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 25682-016-01 [25682001601]

STRENSIQ SOLUTION

• Marketing Category: BLA
• Application Number: BLA125513
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-10-23

NDC 25682-016-12 [25682001612]

STRENSIQ SOLUTION

• Marketing Category: BLA
• Application Number: BLA125513
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-10-23

Drug Details

Active Ingredients

Ingredient	Strength
ASFOTASE ALFA	40 mg/mL

OpenFDA Data

• SPL SET ID: 3387574f-5eaa-4501-a71d-4cbfbd563031
• Manufacturer:
  • Alexion Pharmaceuticals, Inc.
• UNII:
  • Z633861EIM
• 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"

NDC	Brand Name	Generic Name
25682-010	STRENSIQ	ASFOTASE ALFA
25682-013	STRENSIQ	ASFOTASE ALFA
25682-016	STRENSIQ	ASFOTASE ALFA
25682-019	STRENSIQ	ASFOTASE ALFA