gamifant

Generic: emapalumab-lzsg

Labeler: swedish orphan biovitrum ab (publ)
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name gamifant
Generic Name emapalumab-lzsg
Labeler swedish orphan biovitrum ab (publ)
Dosage Form INJECTION
Routes
INTRAVENOUS
Active Ingredients

emapalumab 500 mg/20mL

Manufacturer
Swedish Orphan Biovitrum AB (publ)

Identifiers & Regulatory

Product NDC 66658-525
Product ID 66658-525_8ad514da-e74a-48bb-bcd1-6c8b39cb89f9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761107
Listing Expiration 2026-12-31
Marketing Start 2023-06-07

Pharmacologic Class

Established (EPC)
interferon gamma blocker [epc]
Mechanism of Action
interferon gamma antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 66658525
Hyphenated Format 66658-525

Supplemental Identifiers

RxCUI
2104611 2104616 2104621 2104622 2380771 2380772 2665325 2665328 2665330 2665331 2665332 2665333 2665334 2665335
UNII
3S252O2Z4X
NUI
N0000193856 N0000193855

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 gamifant (source: ndc)
Generic Name emapalumab-lzsg (source: ndc)
Application Number BLA761107 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 500 mg/20mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (66658-525-01) / 20 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

66658-525-01 1 VIAL, SINGLE-USE in 1 CARTON (66658-525-01) / 20 mL in 1 VIAL, SINGLE-USE

Ingredients (1)

emapalumab (500 mg/20mL)

Linked Drug Pages (1)

GAMIFANT ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "8ad514da-e74a-48bb-bcd1-6c8b39cb89f9", "openfda": {"nui": ["N0000193856", "N0000193855"], "unii": ["3S252O2Z4X"], "rxcui": ["2104611", "2104616", "2104621", "2104622", "2380771", "2380772", "2665325", "2665328", "2665330", "2665331", "2665332", "2665333", "2665334", "2665335"], "spl_set_id": ["a865e0ef-8685-4f69-8838-648c4f3bab47"], "pharm_class_epc": ["Interferon gamma Blocker [EPC]"], "pharm_class_moa": ["Interferon gamma Antagonists [MoA]"], "manufacturer_name": ["Swedish Orphan Biovitrum AB (publ)"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (66658-525-01)  / 20 mL in 1 VIAL, SINGLE-USE", "package_ndc": "66658-525-01", "marketing_start_date": "20230607"}], "brand_name": "GAMIFANT", "product_id": "66658-525_8ad514da-e74a-48bb-bcd1-6c8b39cb89f9", "dosage_form": "INJECTION", "pharm_class": ["Interferon gamma Antagonists [MoA]", "Interferon gamma Blocker [EPC]"], "product_ndc": "66658-525", "generic_name": "emapalumab-lzsg", "labeler_name": "Swedish Orphan Biovitrum AB (publ)", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GAMIFANT", "active_ingredients": [{"name": "EMAPALUMAB", "strength": "500 mg/20mL"}], "application_number": "BLA761107", "marketing_category": "BLA", "marketing_start_date": "20230607", "listing_expiration_date": "20261231"}