strensiq

Generic: asfotase alfa

Labeler: alexion pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name strensiq
Generic Name asfotase alfa
Labeler alexion pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
SUBCUTANEOUS
Active Ingredients

asfotase alfa 40 mg/mL

Manufacturer
Alexion Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 25682-016
Product ID 25682-016_404d99e5-991e-4353-bb9f-29dfa00a43b3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125513
Listing Expiration 2026-12-31
Marketing Start 2015-10-23

Pharmacologic Class

Established (EPC)
tissue-nonspecific alkaline phosphatase [epc]
Chemical Structure
alkaline phosphatase [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25682016
Hyphenated Format 25682-016

Supplemental Identifiers

RxCUI
1720263 1720268 1720271 1720272 1720275 1720276 1720278 1720280
UNII
Z633861EIM
NUI
N0000191865 M0000712

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name strensiq (source: ndc)
Generic Name asfotase alfa (source: ndc)
Application Number BLA125513 (source: ndc)
Routes
SUBCUTANEOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 12 VIAL in 1 CARTON (25682-016-12) / 1 mL in 1 VIAL (25682-016-01)
source: ndc

Packages (1)

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

Ingredients (1)

asfotase alfa (40 mg/mL)

Linked Drug Pages (1)

STRENSIQ ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["SUBCUTANEOUS"], "spl_id": "404d99e5-991e-4353-bb9f-29dfa00a43b3", "openfda": {"nui": ["N0000191865", "M0000712"], "unii": ["Z633861EIM"], "rxcui": ["1720263", "1720268", "1720271", "1720272", "1720275", "1720276", "1720278", "1720280"], "spl_set_id": ["3387574f-5eaa-4501-a71d-4cbfbd563031"], "pharm_class_cs": ["Alkaline Phosphatase [CS]"], "pharm_class_epc": ["Tissue-nonspecific Alkaline Phosphatase [EPC]"], "manufacturer_name": ["Alexion Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 VIAL in 1 CARTON (25682-016-12)  / 1 mL in 1 VIAL (25682-016-01)", "package_ndc": "25682-016-12", "marketing_start_date": "20151023"}], "brand_name": "STRENSIQ", "product_id": "25682-016_404d99e5-991e-4353-bb9f-29dfa00a43b3", "dosage_form": "SOLUTION", "pharm_class": ["Alkaline Phosphatase [CS]", "Tissue-nonspecific Alkaline Phosphatase [EPC]"], "product_ndc": "25682-016", "generic_name": "ASFOTASE ALFA", "labeler_name": "Alexion Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "STRENSIQ", "active_ingredients": [{"name": "ASFOTASE ALFA", "strength": "40 mg/mL"}], "application_number": "BLA125513", "marketing_category": "BLA", "marketing_start_date": "20151023", "listing_expiration_date": "20261231"}