Prescription drug · BLA
Saphnelo (Anifrolumab-fnia) NDC 0310-3080
Anifrolumab 120 mg/.8mL · Injection, Solution · Subcutaneous · AstraZeneca Pharmaceuticals LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0310-3080-01 | 00310308001 | 1 SYRINGE, GLASS in 1 CARTON (0310-3080-01) / .8 mL in 1 SYRINGE, GLASS (0310-3080-25)Marketed from Apr 24, 2026 | |
| 0310-3080-02 | 00310308002 | 1 SYRINGE, GLASS in 1 CARTON (0310-3080-02) / .8 mL in 1 SYRINGE, GLASS (0310-3080-75)Marketed from Apr 24, 2026 | |
| 0310-3080-95 | 00310308095 | 1 SYRINGE, GLASS in 1 CARTON (0310-3080-95) / .8 mL in 1 SYRINGE, GLASS (0310-3080-25)Marketed from Apr 24, 2026 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Saphnelo
- Generic name (nonproprietary)
- anifrolumab-fnia
- Active ingredients
- Anifrolumab — 120 mg/.8mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- AstraZeneca Pharmaceuticals LPNDC labeler code 0310
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761451
- Marketing start
- Listing expires
- Other FDA classes
- Type I Interferon Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0310-3080_810dc1a8-73e1-41fc-874f-2dd1d8ed1429SPL ID 810dc1a8-73e1-41fc-874f-2dd1d8ed1429SPL set ID d6203302-2128-41a7-b0b4-0e6c0704d4dcRxCUI 2565280, 2565286, 2741470, 2741474, 2741478, 2741482UNII 38RL9AE51Q
- Pharmacologic class
- Type I Interferon Receptor Antagonist
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
N400310308001followed by a unit qualifier and the quantityPackage 00310-3080-01. 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)
SAPHNELO is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. Limitations of Use The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. Use of SAPHNELO is not recommended in these situations. SAPHNELO is a type I interferon (IFN) receptor antagonist indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy. ( 1 ) Limitations of Use: The efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or sever…
Excerpt only. Read the full label for complete information.
About NDC 0310-3080
- What is NDC 0310-3080?
- 0310-3080 is the product NDC for Saphnelo (anifrolumab-fnia), Anifrolumab 120 mg/.8mL injection, solution, listed with the FDA by AstraZeneca Pharmaceuticals LP. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Saphnelo (Anifrolumab-fnia).
- What is the active ingredient?
- Anifrolumab.
- Who is the labeler?
- AstraZeneca Pharmaceuticals LP, NDC labeler code 0310. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Saphnelo?
- 1 other product NDC are listed under this name. See all Saphnelo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Saphnelo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Saphneloanifrolumab-fnia | Anifrolumab 300 mg/2mL | Injection, SolutionIntravenous | AstraZeneca Pharmaceuticals LP | 0310-3040 | 00310-3040-00 |