Prescription drug · BLA
Strensiq (Asfotase alfa) NDC 25682-010
Asfotase alfa 18 mg/.45mL · Solution · Subcutaneous · Alexion Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25682-010-12 | 25682001012 | 12 VIAL in 1 CARTON (25682-010-12) / .45 mL in 1 VIAL (25682-010-01)Marketed from Oct 23, 2015 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Strensiq
- Generic name (nonproprietary)
- asfotase alfa
- Active ingredients
- Asfotase alfa — 18 mg/.45mL
- Dosage form
- Solution
- Route
- Subcutaneous
- Labeler
- Alexion Pharmaceuticals, Inc.NDC labeler code 25682
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125513
- Marketing start
- Listing expires
- Other FDA classes
- Alkaline Phosphatase (Chemical structure)
- Identifiers
- Product ID 25682-010_404d99e5-991e-4353-bb9f-29dfa00a43b3SPL ID 404d99e5-991e-4353-bb9f-29dfa00a43b3SPL set ID 3387574f-5eaa-4501-a71d-4cbfbd563031RxCUI 1720263, 1720268, 1720271, 1720272, 1720275, 1720276, 1720278, 1720280UNII Z633861EIM
- Pharmacologic class
- Tissue-nonspecific Alkaline Phosphatase
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N425682001012followed by a unit qualifier and the quantityPackage 25682-0010-12. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
STRENSIQ ® is indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). STRENSIQ is a tissue nonspecific alkaline phosphatase indicated for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP). ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 25682-010
- What is NDC 25682-010?
- 25682-010 is the product NDC for Strensiq (asfotase alfa), Asfotase alfa 18 mg/.45mL solution, listed with the FDA by Alexion Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Strensiq (Asfotase alfa).
- What is the active ingredient?
- Asfotase alfa.
- Who is the labeler?
- Alexion Pharmaceuticals, Inc., NDC labeler code 25682. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Strensiq?
- 3 other product NDCs are listed under this name. See all Strensiq NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Strensiq products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Strensiqasfotase alfa | Asfotase alfa 28 mg/.7mL | SolutionSubcutaneous | Alexion Pharmaceuticals, Inc. | 25682-013 | 25682-0013-12 |
| Strensiqasfotase alfa | Asfotase alfa 40 mg/mL | SolutionSubcutaneous | Alexion Pharmaceuticals, Inc. | 25682-016 | 25682-0016-12 |
| Strensiqasfotase alfa | Asfotase alfa 80 mg/.8mL | SolutionSubcutaneous | Alexion Pharmaceuticals, Inc. | 25682-019 | 25682-0019-12 |
Other NDCs under BLA 125513
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Strensiqasfotase alfa | Asfotase alfa 28 mg/.7mL | SolutionSubcutaneous | Alexion Pharmaceuticals, Inc. | 25682-013 |
| Strensiqasfotase alfa | Asfotase alfa 40 mg/mL | SolutionSubcutaneous | Alexion Pharmaceuticals, Inc. | 25682-016 |
| Strensiqasfotase alfa | Asfotase alfa 80 mg/.8mL | SolutionSubcutaneous | Alexion Pharmaceuticals, Inc. | 25682-019 |