Prescription drug · NDA
Dawnzera (donidalorsen) NDC 71860-103
Donidalorsen sodium 80 mg/.8mL · Injection, Solution · Subcutaneous · Ionis Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71860-103-01 | 71860010301 | 1 SYRINGE, GLASS in 1 CARTON (71860-103-01) / .8 mL in 1 SYRINGE, GLASSMarketed from Aug 21, 2025 |
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)
- Dawnzera
- Generic name (nonproprietary)
- donidalorsen
- Active ingredients
- Donidalorsen sodium — 80 mg/.8mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Ionis Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219407
- Marketing start
- Listing expires
- Identifiers
- Product ID 71860-103_3f909bfc-3281-a444-e063-6294a90a221fSPL ID 3f909bfc-3281-a444-e063-6294a90a221fSPL set ID 3ff501e0-f75f-07da-e063-6294a90a0cb7RxCUI 2724447, 2724453UNII Y30VEG5PH1
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
N471860010301followed by a unit qualifier and the quantityPackage 71860-0103-01. 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 .
Indications (excerpt from the label)
DAWNZERA™ is indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. DAWNZERA is a prekallikrein directed antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adult and pediatric patients 12 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.