GAMMAKED

Product NDC: 76125-900
Requested package NDC: 76125-900-20
11-digit product format: 761250900
Labeler code: 76125
Product ID: 76125-900_a7b621b8-b33b-4ece-b7ba-7d63f8ec7018
Type: PLASMA DERIVATIVE
Nonproprietary name: Immune Globulin (Human)
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: KEDRION BIOPHARMA, INC.
Application: BLA125046
Marketing category: BLA
Marketing start: 2010-10-13
Substance: HUMAN IMMUNOGLOBULIN G
Active strength: 10 g/100mL
Pharmacologic classes: Antigen Neutralization [MoA], Human Immunoglobulin G [EPC], Immunoglobulins [CS], Passively Acquired Immunity [PE]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: GAMMAKED
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	10 g/100mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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	SPL version
76125-900-01	GAMMAKED	1 in 1 CARTON	INJECTION	1	34
76125-900-02	GAMMAKED	10 mL in 1 VIAL, GLASS	INJECTION	10	34
76125-900-10	GAMMAKED	1 in 1 CARTON	INJECTION	1	34
76125-900-11	GAMMAKED	100 mL in 1 VIAL, GLASS	INJECTION	100	34
76125-900-20	GAMMAKED	1 in 1 CARTON	INJECTION	1	34
76125-900-21	GAMMAKED	200 mL in 1 VIAL, GLASS	INJECTION	200	34
76125-900-25	GAMMAKED	1 in 1 CARTON	INJECTION	1	34
76125-900-26	GAMMAKED	25 mL in 1 VIAL, GLASS	INJECTION	25	34
76125-900-50	GAMMAKED	1 in 1 CARTON	INJECTION	1	34
76125-900-51	GAMMAKED	50 mL in 1 VIAL, GLASS	INJECTION	50	34

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76125-900-01	ML - Milliliter	76125-900	2dd638ae-412b-4d51-9adf-656a54cba0b4	1	2012-07-24
76125-900-10	ML - Milliliter	76125-900	951388e4-506d-4414-8b2d-438163430923	1	2012-07-24
76125-900-11	ML - Milliliter	76125-900	1b3e79b8-af3b-4347-9106-27fe236cdd6c	1	2019-08-06
76125-900-20	ML - Milliliter	76125-900	9ad24f0e-2ecb-4dc1-9f8b-eafa86fdced8	1	2012-07-24
76125-900-21	ML - Milliliter	76125-900	4466bd0c-0ec3-429a-91e5-3d4bedd7423c	1	2019-08-06
76125-900-25	ML - Milliliter	76125-900	d8e27645-2f98-4953-ae3a-a9cb9145eb4a	1	2012-07-24
76125-900-50	ML - Milliliter	76125-900	8455e497-7e71-40b5-ace4-7297aed64171	1	2012-07-24
76125-900-51	ML - Milliliter	76125-900	b9109880-ebdb-4448-80fd-06a6808643b9	1	2019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Human Immunoglobulin G	ACTIVE INGREDIENT	66Y330CJHS	GAMMAKED (HUMAN IMMUNOGLOBULIN G) INJECTION [KEDRION BIOPHARMA, INC]	18
Human Immunoglobulin G	ACTIVE MOIETY	66Y330CJHS	GAMMAKED (HUMAN IMMUNOGLOBULIN G) INJECTION [KEDRION BIOPHARMA, INC]	18
Glycine	INACTIVE INGREDIENT	TE7660XO1C	GAMMAKED (HUMAN IMMUNOGLOBULIN G) INJECTION [KEDRION BIOPHARMA, INC]	18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76125-900	GAMMAKED (IMMUNE GLOBULIN (HUMAN)) INJECTION [KEDRION BIOPHARMA, INC.]	34	Current NDC, Legacy NDC, 10 package rows	20210727_8c004331-7a91-8046-7510-9b9b7d33ced7.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125046	Gammaked, Gamunex-C	Immune Globulin Injection (Human) 10% Caprylate/Chromatography Purified	351(a)	Rx	2026-09-01

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
66Y330CJHS	HUMAN IMMUNOGLOBULIN G	308067-58-5	HUMAN IMMUNOGLOBULIN G

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1809436	gammaked 10 % in 10 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809441	gammaked 10 % in 100 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809445	gammaked 10 % in 200 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809439	gammaked 10 % in 25 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809440	gammaked 10 % in 50 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809434	immunoglobulin G, human 10 % in 10 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809421	immunoglobulin G, human 10 % in 100 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809444	immunoglobulin G, human 10 % in 200 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809438	immunoglobulin G, human 10 % in 25 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809414	immunoglobulin G, human 10 % in 50 ML Injection	PSN	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809436	10 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]	SBD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809441	100 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]	SBD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809445	200 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]	SBD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809439	25 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]	SBD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809440	50 ML immunoglobulin G, human 100 MG/ML Injection [Gammaked]	SBD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809434	10 ML immunoglobulin G, human 100 MG/ML Injection	SCD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809421	100 ML immunoglobulin G, human 100 MG/ML Injection	SCD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809444	200 ML immunoglobulin G, human 100 MG/ML Injection	SCD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809438	25 ML immunoglobulin G, human 100 MG/ML Injection	SCD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809414	50 ML immunoglobulin G, human 100 MG/ML Injection	SCD	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809436	10 ML Gammaked 100 MG/ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809441	100 ML Gammaked 100 MG/ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809445	200 ML Gammaked 100 MG/ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809439	25 ML Gammaked 100 MG/ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809440	50 ML Gammaked 100 MG/ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809436	Gammaked 1 GM per 10 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809436	Gammaked 10 % per 10 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809441	Gammaked 10 % per 100 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809445	Gammaked 10 % per 200 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809439	Gammaked 10 % per 25 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809440	Gammaked 10 % per 50 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809441	Gammaked 10 GM per 100 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809439	Gammaked 2.5 GM per 25 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809445	Gammaked 20 GM per 200 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809440	Gammaked 5 GM per 50 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809434	immunoglobulin G, human 1 GM per 10 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809434	immunoglobulin G, human 10 % per 10 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809421	immunoglobulin G, human 10 % per 100 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809444	immunoglobulin G, human 10 % per 200 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809438	immunoglobulin G, human 10 % per 25 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809414	immunoglobulin G, human 10 % per 50 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809421	immunoglobulin G, human 10 GM per 100 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809438	immunoglobulin G, human 2.5 GM per 25 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809444	immunoglobulin G, human 20 GM per 200 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34
1809414	immunoglobulin G, human 5 GM per 50 ML Injection	SY	8c004331-7a91-8046-7510-9b9b7d33ced7	34

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76125-900-20	76125090020	1 VIAL, GLASS in 1 CARTON (76125-900-20) / 200 mL in 1 VIAL, GLASS (76125-900-21)	2010-10-13	0000-00-00	No	No	Current

GAMMAKED

Reported adverse events (FAERS/openFDA)#

Additional Listing Data#

Active Ingredients#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Purple Book Biologic Products#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#