GAMMAGARD Liquid

Product NDC: 0944-2700
11-digit product format: 009442700
Labeler code: 0944
Product ID: 0944-2700_22fa0cdc-9566-4219-ba2b-2f2122370641
Type: PLASMA DERIVATIVE
Nonproprietary name: Immune Globulin Infusion (Human)
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: Takeda Pharmaceuticals America, Inc.
Application: BLA125105
Marketing category: BLA
Marketing start: 2005-04-27
Substance: HUMAN IMMUNOGLOBULIN G
Active strength: 100 mg/mL
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HUMAN IMMUNOGLOBULIN G	100 mg/mL

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
0944-2700-02	GAMMAGARD Liquid	1 in 1 CARTON	INJECTION, SOLUTION	1	22
0944-2700-03	GAMMAGARD Liquid	1 in 1 CARTON	INJECTION, SOLUTION	1	22
0944-2700-04	GAMMAGARD Liquid	1 in 1 CARTON	INJECTION, SOLUTION	1	22
0944-2700-05	GAMMAGARD Liquid	1 in 1 CARTON	INJECTION, SOLUTION	1	22
0944-2700-06	GAMMAGARD Liquid	1 in 1 CARTON	INJECTION, SOLUTION	1	22
0944-2700-07	GAMMAGARD Liquid	1 in 1 CARTON	INJECTION, SOLUTION	1	22
0944-2700-08	GAMMAGARD Liquid	10 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	10	22
0944-2700-09	GAMMAGARD Liquid	25 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	25	22
0944-2700-10	GAMMAGARD Liquid	50 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	50	22
0944-2700-11	GAMMAGARD Liquid	100 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	100	22
0944-2700-12	GAMMAGARD Liquid	200 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	200	22
0944-2700-13	GAMMAGARD Liquid	300 mL in 1 BOTTLE, GLASS	INJECTION, SOLUTION	300	22

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0944-2700-02	ML - Milliliter	0944-2700	45cad975-7bbe-40f9-844b-2077eefa2b5f	1	2012-07-24
0944-2700-03	ML - Milliliter	0944-2700	2615711d-ffa7-4213-ba2b-1a7e58049dec	1	2012-07-24
0944-2700-04	ML - Milliliter	0944-2700	16b54f6c-f3a9-4c3d-aab8-90abb601ccae	1	2012-07-24
0944-2700-05	ML - Milliliter	0944-2700	c79ff73d-0d05-438a-8c2e-c6c308a0b31b	1	2012-07-24
0944-2700-06	ML - Milliliter	0944-2700	1ee530f5-7a58-4327-a2e4-6868c8a5c9bd	1	2012-07-24
0944-2700-07	ML - Milliliter	0944-2700	cbc0badc-ec2a-4f60-8749-d5d1a6f84518	1	2012-07-24
0944-2700-08	ML - Milliliter	0944-2700	2d8bae4b-d97c-48e4-937e-f5b4c9717eec	1	2017-07-07
0944-2700-09	ML - Milliliter	0944-2700	7ec67ecb-2746-402d-add2-a45c4c01fee4	1	2017-07-07
0944-2700-10	ML - Milliliter	0944-2700	0fa6239d-8206-4f66-999c-8af750af4dc9	1	2017-07-07
0944-2700-11	ML - Milliliter	0944-2700	2e332480-3c2b-4d82-8e48-14953d6cc42e	1	2017-07-07
0944-2700-12	ML - Milliliter	0944-2700	acb00184-7db7-4306-a469-62727922e8c7	1	2017-07-07
0944-2700-13	ML - Milliliter	0944-2700	46ae0902-33b1-4ee3-afd6-7063f8bc406a	1	2017-07-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
HUMAN IMMUNOGLOBULIN G	ACTIVE INGREDIENT	66Y330CJHS	GAMMAGARD (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
HUMAN IMMUNOGLOBULIN G	ACTIVE MOIETY	66Y330CJHS	GAMMAGARD (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	GAMMAGARD (HUMAN IMMUNOGLOBULIN G) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0944-2700	GAMMAGARD LIQUID (IMMUNE GLOBULIN INFUSION (HUMAN)) INJECTION, SOLUTION [TAKEDA PHARMACEUTICALS AMERICA, INC.]	21	Current NDC, Legacy NDC, 12 package rows	20241121_9d42adca-0dd7-4df7-864d-5a7feee52130.zip

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
1809665	GAMMAGARD 10 % in 10 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809670	GAMMAGARD 10 % in 100 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809671	GAMMAGARD 10 % in 200 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809667	GAMMAGARD 10 % in 25 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809672	GAMMAGARD 10 % in 300 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809668	GAMMAGARD 10 % in 50 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809434	immunoglobulin G, human 10 % in 10 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809421	immunoglobulin G, human 10 % in 100 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809444	immunoglobulin G, human 10 % in 200 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809438	immunoglobulin G, human 10 % in 25 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809539	immunoglobulin G, human 10 % in 300 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809414	immunoglobulin G, human 10 % in 50 ML Injection	PSN	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809665	10 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard]	SBD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809670	100 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard]	SBD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809671	200 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard]	SBD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809667	25 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard]	SBD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809672	300 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard]	SBD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809668	50 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard]	SBD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809434	10 ML immunoglobulin G, human 100 MG/ML Injection	SCD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809421	100 ML immunoglobulin G, human 100 MG/ML Injection	SCD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809444	200 ML immunoglobulin G, human 100 MG/ML Injection	SCD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809438	25 ML immunoglobulin G, human 100 MG/ML Injection	SCD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809539	300 ML immunoglobulin G, human 100 MG/ML Injection	SCD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809414	50 ML immunoglobulin G, human 100 MG/ML Injection	SCD	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809665	10 ML Gammagard 100 MG/ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809670	100 ML Gammagard 100 MG/ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809671	200 ML Gammagard 100 MG/ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809667	25 ML Gammagard 100 MG/ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809672	300 ML Gammagard 100 MG/ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809668	50 ML Gammagard 100 MG/ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809665	Gammagard 1 GM per 10 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809665	Gammagard 10 % per 10 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809670	Gammagard 10 % per 100 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809671	Gammagard 10 % per 200 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809667	Gammagard 10 % per 25 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809672	Gammagard 10 % per 300 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809668	Gammagard 10 % per 50 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809670	Gammagard 10 GM per 100 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809667	Gammagard 2.5 GM per 25 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809671	Gammagard 20 GM per 200 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809672	Gammagard 30 GM per 300 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809668	Gammagard 5 GM per 50 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809434	immunoglobulin G, human 1 GM per 10 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809434	immunoglobulin G, human 10 % per 10 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809421	immunoglobulin G, human 10 % per 100 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809444	immunoglobulin G, human 10 % per 200 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809438	immunoglobulin G, human 10 % per 25 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809539	immunoglobulin G, human 10 % per 300 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809414	immunoglobulin G, human 10 % per 50 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809421	immunoglobulin G, human 10 GM per 100 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809438	immunoglobulin G, human 2.5 GM per 25 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809444	immunoglobulin G, human 20 GM per 200 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22
1809414	immunoglobulin G, human 5 GM per 50 ML Injection	SY	9d42adca-0dd7-4df7-864d-5a7feee52130	22

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0944-2700-02	00944270002	1 BOTTLE, GLASS in 1 CARTON (0944-2700-02) / 10 mL in 1 BOTTLE, GLASS (0944-2700-08)		2005-04-27	0000-00-00	No	No	Current
0944-2700-03	00944270003	1 BOTTLE, GLASS in 1 CARTON (0944-2700-03) / 25 mL in 1 BOTTLE, GLASS (0944-2700-09)		2005-04-27	0000-00-00	No	No	Current
0944-2700-04	00944270004	1 BOTTLE, GLASS in 1 CARTON (0944-2700-04) / 50 mL in 1 BOTTLE, GLASS (0944-2700-10)		2005-04-27	0000-00-00	No	No	Current
0944-2700-05	00944270005	1 BOTTLE, GLASS in 1 CARTON (0944-2700-05) / 100 mL in 1 BOTTLE, GLASS (0944-2700-11)		2005-04-27	0000-00-00	No	No	Current
0944-2700-06	00944270006	1 BOTTLE, GLASS in 1 CARTON (0944-2700-06) / 200 mL in 1 BOTTLE, GLASS (0944-2700-12)		2005-04-27	0000-00-00	No	No	Current
0944-2700-07	00944270007	1 BOTTLE, GLASS in 1 CARTON (0944-2700-07) / 300 mL in 1 BOTTLE, GLASS (0944-2700-13)		2005-04-27	0000-00-00	No	No	Current
0944-2700-08	00944270008	10 mL in 1 BOTTLE, GLASS	10 ml					Historical
0944-2700-09	00944270009	25 mL in 1 BOTTLE, GLASS	25 ml					Historical
0944-2700-10	00944270010	50 mL in 1 BOTTLE, GLASS	50 ml					Historical
0944-2700-11	00944270011	100 mL in 1 BOTTLE, GLASS	100 ml					Historical
0944-2700-12	00944270012	200 mL in 1 BOTTLE, GLASS	200 ml					Historical
0944-2700-13	00944270013	300 mL in 1 BOTTLE, GLASS	300 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GAMMAGARD Liquid	Takeda Pharmaceuticals America, Inc. \| Baxalta Belgium Manufacturing SA \| Baxalta US Inc.	2025-12-10	PLASMA DERIVATIVE	22

GAMMAGARD Liquid

Additional Listing Data#

Active Ingredients#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

Related Records#

Related UNII Ingredients#

DailyMed RxNorm Mappings#

Packages#

Related DailyMed Labels#