Saphnelo Injection, Solution
NDC Package 0310-3080-95

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Saphnelo (anifrolumab-fnia) injection is sAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy [see Clinical Studies (14)].Limitations of UseThe efficacy of SAPHNELO has not been evaluated in patients with severe active lupus nephritis or severe active central nervous system lupus. This formulation utilizes a injection, solution delivery system. Marketed by Astrazeneca Pharmaceuticals Lp, this product is identified by NDC 0310-3080 and is authorized under FDA application BLA761451.

Identification & Billing

NDC Package Code
0310-3080-95
Package Description
1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS (0310-3080-25)
Product Code
0310-3080
11-Digit Billing Format
00310308095
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Saphnelo
Non-Proprietary Name
Anifrolumab-fnia
Substance Name
Anifrolumab
Dosage Form
Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.
Administration Route
Subcutaneous - Administration beneath the skin; hypodermic. Synonymous with the term SUBDERMAL.
Active Ingredient(s)
ANIFROLUMAB 120 mg/.8mL
Pharmacologic Class
Usage Information
SAPHNELO (anifrolumab-fnia) is indicated for the treatment of adult patients with moderate to severe systemic lupus erythematosus (SLE), who are receiving standard therapy [see Clinical Studies (14)].Limitations of UseThe 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.

Regulatory & Marketing

Labeler Name
Astrazeneca Pharmaceuticals Lp
Product Type
Human Prescription Drug
FDA Application #
BLA761451
Marketing Category
BLA - A product marketed under an approved Biologic License Application.
Start Marketing Date
04-24-2026
Listing Expiration
12-31-2027
Exclude Flag
N
Sample Package
Yes

Hierarchy Structure

Code Lineage

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (0310-3080). Click a package code to view its specific billing and regulatory data.

0310-3080-01
1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS (0310-3080-25)
0310-3080-02
1 SYRINGE, GLASS in 1 CARTON / .8 mL in 1 SYRINGE, GLASS (0310-3080-75)

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 0310-3080-95 identifies a specific commercial package of 1 syringe, glass in 1 carton / .8 ml in 1 syringe, glass (0310-3080-25) of Saphnelo, a human prescription drug labeled by Astrazeneca Pharmaceuticals Lp. This injection, solution is formulated for subcutaneous use and contains anifrolumab as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Astrazeneca Pharmaceuticals Lp on April 24, 2026. The current certification is valid through December 31, 2027.

How is this Astrazeneca Pharmaceuticals Lp product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 00310308095. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (4-4-2)
0310-3080-95
11-Digit CMS (5-4-2)
00310-3080-95

Note: The zero is added to the Labeler segment to maintain the 5-4-2 structure.