GAMIFANT

Product NDC: 66658-523
11-digit product format: 666580523
Labeler code: 66658
Product ID: 66658-523_58d52c0a-08fe-40f4-86ba-752dd079ec91
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: emapalumab-lzsg
Dosage form: INJECTION
Route: INTRAVENOUS
Labeler: Swedish Orphan Biovitrum AB (publ)
Application: BLA761107
Marketing category: BLA
Marketing start: 2023-06-07
Substance: EMAPALUMAB
Active strength: 100 mg/4mL
Pharmacologic classes: Interferon gamma Antagonists [MoA], Interferon gamma Blocker [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EMAPALUMAB	100 mg/4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3S252O2Z4X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 14 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2104611	Internal RxNorm lookup
2104616	Internal RxNorm lookup
2104621	Internal RxNorm lookup
2104622	Internal RxNorm lookup
2380771	Internal RxNorm lookup
2380772	Internal RxNorm lookup
2665325	Internal RxNorm lookup
2665328	Internal RxNorm lookup
2665330	Internal RxNorm lookup
2665331	Internal RxNorm lookup
2665332	Internal RxNorm lookup
2665333	Internal RxNorm lookup
2665334	Internal RxNorm lookup
2665335	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a865e0ef-8685-4f69-8838-648c4f3bab47	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9710cae2-c58b-4816-a4fe-1da980345dda	Product name	1	20190222
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 table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
66658-523-01	GAMIFANT	4 mL in 1 VIAL, SINGLE-USE	INJECTION	4		10
66658-523-01	GAMIFANT	1 in 1 CARTON	INJECTION	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66658-523	GAMIFANT (EMAPALUMAB-LZSG) INJECTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]	8	Current NDC, 2 package rows	20241011_a865e0ef-8685-4f69-8838-648c4f3bab47.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GAMIFANT	EMAPALUMAB-LZSG	Swedish Orphan Biovitrum AB (publ)	a865e0ef-8685-4f69-8838-648c4f3bab47	2026-03-26	Warnings, Adverse reactions	Exact identifier application number: BLA761107 ndc (product): 66658-523

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
761107	Gamifant	emapalumab-lzsg	351(a)	Rx	2026-07-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3S252O2Z4X	EMAPALUMAB	1709815-23-5	EMAPALUMAB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2104611	emapalumab-lzsg 10 MG in 2 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2380771	emapalumab-lzsg 100 MG in 20 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665334	emapalumab-lzsg 100 MG in 4 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665332	emapalumab-lzsg 250 MG in 10 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104621	emapalumab-lzsg 50 MG in 10 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665330	emapalumab-lzsg 50 MG in 2 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665325	emapalumab-lzsg 500 MG in 20 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104616	Gamifant 10 MG in 2 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2380772	Gamifant 100 MG in 20 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665335	Gamifant 100 MG in 4 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665333	Gamifant 250 MG in 10 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104622	Gamifant 50 MG in 10 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665331	Gamifant 50 MG in 2 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665328	Gamifant 500 MG in 20 ML Injection	PSN	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665333	10 ML emapalumab-lzsg 25 MG/ML Injection [Gamifant]	SBD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104622	10 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant]	SBD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665331	2 ML emapalumab-lzsg 25 MG/ML Injection [Gamifant]	SBD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104616	2 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant]	SBD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665328	20 ML emapalumab-lzsg 25 MG/ML Injection [Gamifant]	SBD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2380772	20 ML emapalumab-lzsg 5 MG/ML Injection [Gamifant]	SBD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665335	4 ML emapalumab-lzsg 25 MG/ML Injection [Gamifant]	SBD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665332	10 ML emapalumab-lzsg 25 MG/ML Injection	SCD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104621	10 ML emapalumab-lzsg 5 MG/ML Injection	SCD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665330	2 ML emapalumab-lzsg 25 MG/ML Injection	SCD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104611	2 ML emapalumab-lzsg 5 MG/ML Injection	SCD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665325	20 ML emapalumab-lzsg 25 MG/ML Injection	SCD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2380771	20 ML emapalumab-lzsg 5 MG/ML Injection	SCD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665334	4 ML emapalumab-lzsg 25 MG/ML Injection	SCD	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665333	10 ML Gamifant 25 MG/ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104622	10 ML Gamifant 5 MG/ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665331	2 ML Gamifant 25 MG/ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104616	2 ML Gamifant 5 MG/ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665328	20 ML Gamifant 25 MG/ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2380772	20 ML Gamifant 5 MG/ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665335	4 ML Gamifant 25 MG/ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104611	emapalumab-lzsg 10 MG per 2 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2380771	emapalumab-lzsg 100 MG per 20 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665334	emapalumab-lzsg 100 MG per 4 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665332	emapalumab-lzsg 250 MG per 10 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104621	emapalumab-lzsg 50 MG per 10 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665330	emapalumab-lzsg 50 MG per 2 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665325	emapalumab-lzsg 500 MG per 20 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104616	Gamifant 10 MG per 2 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2380772	Gamifant 100 MG per 20 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665335	Gamifant 100 MG per 4 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665333	Gamifant 250 MG per 10 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2104622	Gamifant 50 MG per 10 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665331	Gamifant 50 MG per 2 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10
2665328	Gamifant 500 MG per 20 ML Injection	SY	a865e0ef-8685-4f69-8838-648c4f3bab47	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
66658-523-01	66658052301	1 VIAL, SINGLE-USE in 1 CARTON (66658-523-01) / 4 mL in 1 VIAL, SINGLE-USE	2023-06-07	No	No	Current