GAMIFANT

Product NDC: 66658-522
11-digit product format: 666580522
Labeler code: 66658
Product ID: 66658-522_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: 50 mg/2mL
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	50 mg/2mL

Harmonized Identifiers#

Field, Values table
Field	Values
Unii	3S252O2Z4X
Rxcui	2104611, 2104616, 2104621, 2104622, 2380771, 2380772, 2665325, 2665328, 2665330, 2665331, 2665332, 2665333, 2665334, 2665335

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
66658-522-01	GAMIFANT	2 mL in 1 VIAL, SINGLE-USE	INJECTION	2		10
66658-522-01	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
66658-522	GAMIFANT (EMAPALUMAB-LZSG) INJECTION [SWEDISH ORPHAN BIOVITRUM AB (PUBL)]	8	Current NDC, 2 package rows	20241011_a865e0ef-8685-4f69-8838-648c4f3bab47.zip

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
66658-522-01	66658052201	1 VIAL, SINGLE-USE in 1 CARTON (66658-522-01) / 2 mL in 1 VIAL, SINGLE-USE	2023-06-07	No	No	Current

GAMIFANT

Additional Listing Data#

Related Records#

Active Ingredients#

Harmonized Identifiers#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#