Home NDC 25682-016 STRENSIQ
Product NDC 25682-016
11-digit product format 256820016
Labeler code 25682
Product ID 25682-016_404d99e5-991e-4353-bb9f-29dfa00a43b3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ASFOTASE ALFA
Dosage form SOLUTION
Route SUBCUTANEOUS
Labeler Alexion Pharmaceuticals, Inc.
Application BLA125513
Marketing category BLA
Marketing start 2015-10-23
Substance ASFOTASE ALFA
Active strength 40 mg/mL
Pharmacologic classes Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base STRENSIQ
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ASFOTASE ALFA 40 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z633861EIM Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1720263 Internal RxNorm lookup 1720268 Internal RxNorm lookup 1720271 Internal RxNorm lookup 1720272 Internal RxNorm lookup 1720275 Internal RxNorm lookup 1720276 Internal RxNorm lookup 1720278 Internal RxNorm lookup 1720280 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 25682-016-01 STRENSIQ 1 mL in 1 VIAL SOLUTION 1 18 25682-016-12 STRENSIQ 12 in 1 CARTON SOLUTION 12 18
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 25682-016 STRENSIQ (ASFOTASE ALFA) SOLUTION [ALEXION PHARMACEUTICALS, INC.] 17 Current NDC, Legacy NDC, 2 package rows 20240719_3387574f-5eaa-4501-a71d-4cbfbd563031.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join STRENSIQ ASFOTASE ALFA Alexion Pharmaceuticals, Inc. 3387574f-5eaa-4501-a71d-4cbfbd563031 2025-12-12 Boxed warning, Warnings, Adverse reactions Exact identifier application number: BLA125513 ndc (product): 25682-016
Purple Book Biologic Products# BLA, Proprietary name, Proper name table BLA Proprietary name Proper name License type Status Latest source 125513 Strensiq asfotase alfa 351(a) Rx 2026-06-01
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 25682-016-01 25682001601 1 mL in 1 VIAL 1 ml Historical 25682-016-12 25682001612 12 VIAL in 1 CARTON (25682-016-12) / 1 mL in 1 VIAL (25682-016-01) 12 vial 2015-10-23 0000-00-00 No No Current