saphnelo

Generic: anifrolumab-fnia

Labeler: astrazeneca pharmaceuticals lp
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name saphnelo
Generic Name anifrolumab-fnia
Labeler astrazeneca pharmaceuticals lp
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

anifrolumab 300 mg/2mL

Manufacturer
AstraZeneca Pharmaceuticals LP

Identifiers & Regulatory

Product NDC 0310-3040
Product ID 0310-3040_1455cd4d-5fb3-4a50-919e-5ae70bb987c8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761123
Listing Expiration 2026-12-31
Marketing Start 2021-07-30

Pharmacologic Class

Established (EPC)
type i interferon receptor antagonist [epc]
Mechanism of Action
type i interferon receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03103040
Hyphenated Format 0310-3040

Supplemental Identifiers

RxCUI
2565280 2565286
UNII
38RL9AE51Q
NUI
N0000193967 N0000193968

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name saphnelo (source: ndc)
Generic Name anifrolumab-fnia (source: ndc)
Application Number BLA761123 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 300 mg/2mL
source: ndc
Packaging
  • 1 VIAL, GLASS in 1 CARTON (0310-3040-00) / 2 mL in 1 VIAL, GLASS
source: ndc

Packages (1)

0310-3040-00 1 VIAL, GLASS in 1 CARTON (0310-3040-00) / 2 mL in 1 VIAL, GLASS

Ingredients (1)

anifrolumab (300 mg/2mL)

Linked Drug Pages (1)

SAPHNELO ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1455cd4d-5fb3-4a50-919e-5ae70bb987c8", "openfda": {"nui": ["N0000193967", "N0000193968"], "unii": ["38RL9AE51Q"], "rxcui": ["2565280", "2565286"], "spl_set_id": ["d6203302-2128-41a7-b0b4-0e6c0704d4dc"], "pharm_class_epc": ["Type I Interferon Receptor Antagonist [EPC]"], "pharm_class_moa": ["Type I Interferon Receptor Antagonists [MoA]"], "manufacturer_name": ["AstraZeneca Pharmaceuticals LP"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, GLASS in 1 CARTON (0310-3040-00)  / 2 mL in 1 VIAL, GLASS", "package_ndc": "0310-3040-00", "marketing_start_date": "20210730"}], "brand_name": "SAPHNELO", "product_id": "0310-3040_1455cd4d-5fb3-4a50-919e-5ae70bb987c8", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Type I Interferon Receptor Antagonist [EPC]", "Type I Interferon Receptor Antagonists [MoA]"], "product_ndc": "0310-3040", "generic_name": "Anifrolumab-fnia", "labeler_name": "AstraZeneca Pharmaceuticals LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "SAPHNELO", "active_ingredients": [{"name": "ANIFROLUMAB", "strength": "300 mg/2mL"}], "application_number": "BLA761123", "marketing_category": "BLA", "marketing_start_date": "20210730", "listing_expiration_date": "20261231"}