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NDC 25682-0016-12 STRENSIQ 40 mg/mL Details
STRENSIQ 40 mg/mL
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 Information
| NDC | 25682-0016 |
|---|---|
| Product ID | 25682-016_218a7adc-f119-4c28-aa84-41d8bc666f4b |
| Associated GPIs | 30905610002040 |
| GCN Sequence Number | 074972 |
| GCN Sequence Number Description | asfotase alfa VIAL 40 MG/ML SUBCUT |
| HIC3 | Z1P |
| HIC3 Description | METABOLIC DISEASE ENZYME REPLACE, HYPOPHOSPHATASIA |
| GCN | 39857 |
| HICL Sequence Number | 042649 |
| HICL Sequence Number Description | ASFOTASE ALFA |
| Brand/Generic | Brand |
| Proprietary Name | STRENSIQ |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | ASFOTASE ALFA |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | SUBCUTANEOUS |
| Active Ingredient Strength | 40 |
| Active Ingredient Units | mg/mL |
| Substance Name | ASFOTASE ALFA |
| Labeler Name | Alexion Pharmaceuticals, Inc. |
| Pharmaceutical Class | Alkaline Phosphatase [CS], Tissue-nonspecific Alkaline Phosphatase [EPC] |
| DEA Schedule | n/a |
| Marketing Category | BLA |
| Application Number | BLA125513 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 25682-0016-12 (25682001612)
| NDC Package Code | 25682-016-12 |
|---|---|
| Billing NDC | 25682001612 |
| Package | 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 |
| Pricing Information | N/A |