SAPHNELO
- Product NDC
- 0310-3080
- 11-digit product format
- 003103080
- Labeler code
- 0310
- Product ID
- 0310-3080_0f042188-8a78-4ed5-b2af-a5b1e75b5f25
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Anifrolumab-fnia
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- AstraZeneca Pharmaceuticals LP
- Application
- BLA761451
- Marketing category
- BLA
- Marketing start
- 2026-04-24
- Substance
- ANIFROLUMAB
- Active strength
- 120 mg/.8mL
- Pharmacologic classes
- Type I Interferon Receptor Antagonist [EPC], Type I Interferon Receptor Antagonists [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- SAPHNELO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| ANIFROLUMAB | 120 mg/.8mL |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| ac039bbc-bf52-420d-b2e7-bd3e37748f4d | Product name | 1 | 20220210 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0310-3080-01 | SAPHNELO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 15 | |
| 0310-3080-02 | SAPHNELO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 15 | |
| 0310-3080-25 | SAPHNELO | 0.8 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.8 | 15 | |
| 0310-3080-75 | SAPHNELO | 0.8 mL in 1 SYRINGE, GLASS | INJECTION, SOLUTION | 0.8 | 15 | |
| 0310-3080-95 | SAPHNELO | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | 15 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0310-3080-01 | ML - Milliliter | 0310-3080 | e33a513d-d147-4b3a-9e96-2f6642777f80 | 1 | 2026-05-22 |
| 0310-3080-25 | ML - Milliliter | 0310-3080 | e7724350-aab3-418b-b138-a9fa05f727ab | 1 | 2026-05-22 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| SAPHNELO | ANIFROLUMAB-FNIA | AstraZeneca Pharmaceuticals LP | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 2026-04-24 | Warnings, Adverse reactions | BLA761451 0310-3080 |
Purple Book Biologic Products#
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 761451 | Saphnelo | anifrolumab-fnia | 351(a) | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2741470 | anifrolumab-fnia 120 MG in 0.8 ML Auto-Injector | PSN | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741478 | anifrolumab-fnia 120 MG in 0.8 ML Prefilled Syringe | PSN | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2565280 | anifrolumab-fnia 300 MG in 2 ML Injection | PSN | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741474 | Saphnelo 120 MG in 0.8 ML Auto-Injector | PSN | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741482 | Saphnelo 120 MG in 0.8 ML Prefilled Syringe | PSN | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2565286 | Saphnelo 300 MG in 2 ML Injection | PSN | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741474 | 0.8 ML anifrolumab-fnia 150 MG/ML Auto-Injector [Saphnelo] | SBD | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741482 | 0.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe [Saphnelo] | SBD | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2565286 | 2 ML anifrolumab-fnia 150 MG/ML Injection [Saphnelo] | SBD | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741470 | 0.8 ML anifrolumab-fnia 150 MG/ML Auto-Injector | SCD | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741478 | 0.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe | SCD | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2565280 | 2 ML anifrolumab-fnia 150 MG/ML Injection | SCD | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2565286 | 2 ML Saphnelo 150 MG/ML Injection | SY | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741470 | anifrolumab-fnia 120 MG per 0.8 ML Auto-Injector | SY | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741478 | anifrolumab-fnia 120 MG per 0.8 ML Prefilled Syringe | SY | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2565280 | anifrolumab-fnia 300 MG per 2 ML Injection | SY | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741474 | Saphnelo 120 MG per 0.8 ML Auto-Injector | SY | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2741482 | Saphnelo 120 MG per 0.8 ML Prefilled Syringe | SY | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
| 2565286 | Saphnelo 300 MG per 2 ML Injection | SY | d6203302-2128-41a7-b0b4-0e6c0704d4dc | 15 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0310-3080-01 | 00310308001 | 1 SYRINGE, GLASS in 1 CARTON (0310-3080-01) / .8 mL in 1 SYRINGE, GLASS (0310-3080-25) | 2026-04-24 | No | No | Current | |
| 0310-3080-02 | 00310308002 | 1 SYRINGE, GLASS in 1 CARTON (0310-3080-02) / .8 mL in 1 SYRINGE, GLASS (0310-3080-75) | 2026-04-24 | No | No | Current | |
| 0310-3080-25 | 00310308025 | 0.8 mL in 1 SYRINGE, GLASS | 0.8 ml | Historical | |||
| 0310-3080-75 | 00310308075 | 0.8 mL in 1 SYRINGE, GLASS | 0.8 ml | Historical | |||
| 0310-3080-95 | 00310308095 | 1 SYRINGE, GLASS in 1 CARTON (0310-3080-95) / .8 mL in 1 SYRINGE, GLASS (0310-3080-25) | 2026-04-24 | Yes | No | Current |