FDA.reportPublic FDA data

SAPHNELO

Product NDC
0310-3040
11-digit product format
003103040
Labeler code
0310
Product ID
0310-3040_0f042188-8a78-4ed5-b2af-a5b1e75b5f25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anifrolumab-fnia
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
BLA761123
Marketing category
BLA
Marketing start
2021-07-30
Substance
ANIFROLUMAB
Active strength
300 mg/2mL
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 table
IngredientStrength
ANIFROLUMAB300 mg/2mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ac039bbc-bf52-420d-b2e7-bd3e37748f4dProduct name120220210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-3040-00SAPHNELO2.0 mL in 1 VIAL, GLASSINJECTION, SOLUTION2.015
0310-3040-00SAPHNELO1 in 1 CARTONINJECTION, SOLUTION115

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-3040-00ML - Milliliter0310-30409825e377-0639-4f4f-ad2e-734bc8c62c0f12021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-3040SAPHNELO (ANIFROLUMAB-FNIA) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]12Current NDC, Legacy NDC, 2 package rows20240823_d6203302-2128-41a7-b0b4-0e6c0704d4dc.zip

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SAPHNELOANIFROLUMAB-FNIAAstraZeneca Pharmaceuticals LPd6203302-2128-41a7-b0b4-0e6c0704d4dc2026-04-24Warnings, Adverse reactionsExact identifier
application number: BLA761123
ndc (product): 0310-3040

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761123Saphneloanifrolumab-fnia351(a)Rx2026-09-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2741470anifrolumab-fnia 120 MG in 0.8 ML Auto-InjectorPSNd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2741478anifrolumab-fnia 120 MG in 0.8 ML Prefilled SyringePSNd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2565280anifrolumab-fnia 300 MG in 2 ML InjectionPSNd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2741474Saphnelo 120 MG in 0.8 ML Auto-InjectorPSNd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2741482Saphnelo 120 MG in 0.8 ML Prefilled SyringePSNd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2565286Saphnelo 300 MG in 2 ML InjectionPSNd6203302-2128-41a7-b0b4-0e6c0704d4dc15
27414740.8 ML anifrolumab-fnia 150 MG/ML Auto-Injector [Saphnelo]SBDd6203302-2128-41a7-b0b4-0e6c0704d4dc15
27414820.8 ML anifrolumab-fnia 150 MG/ML Prefilled Syringe [Saphnelo]SBDd6203302-2128-41a7-b0b4-0e6c0704d4dc15
25652862 ML anifrolumab-fnia 150 MG/ML Injection [Saphnelo]SBDd6203302-2128-41a7-b0b4-0e6c0704d4dc15
27414700.8 ML anifrolumab-fnia 150 MG/ML Auto-InjectorSCDd6203302-2128-41a7-b0b4-0e6c0704d4dc15
27414780.8 ML anifrolumab-fnia 150 MG/ML Prefilled SyringeSCDd6203302-2128-41a7-b0b4-0e6c0704d4dc15
25652802 ML anifrolumab-fnia 150 MG/ML InjectionSCDd6203302-2128-41a7-b0b4-0e6c0704d4dc15
25652862 ML Saphnelo 150 MG/ML InjectionSYd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2741470anifrolumab-fnia 120 MG per 0.8 ML Auto-InjectorSYd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2741478anifrolumab-fnia 120 MG per 0.8 ML Prefilled SyringeSYd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2565280anifrolumab-fnia 300 MG per 2 ML InjectionSYd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2741474Saphnelo 120 MG per 0.8 ML Auto-InjectorSYd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2741482Saphnelo 120 MG per 0.8 ML Prefilled SyringeSYd6203302-2128-41a7-b0b4-0e6c0704d4dc15
2565286Saphnelo 300 MG per 2 ML InjectionSYd6203302-2128-41a7-b0b4-0e6c0704d4dc15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0310-3040-00003103040001 VIAL, GLASS in 1 CARTON (0310-3040-00) / 2 mL in 1 VIAL, GLASS2021-07-300000-00-00NoNoCurrent