FDA.reportPublic FDA data

SAPHNELO

Product NDC
0310-3040
11-digit product format
003103040
Labeler code
0310
Product ID
0310-3040_810dc1a8-73e1-41fc-874f-2dd1d8ed1429
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

Additional Listing Data#

Finished product
Yes
Brand name base
SAPHNELO
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANIFROLUMAB300 mg/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii38RL9AE51Q
Rxcui2565280, 2565286, 2741470, 2741474, 2741478, 2741482

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

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