GAMMAGARD Liquid

Product NDC: 0944-2700
Requested package NDC: 0944-2700-06
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

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: GAMMAGARD Liquid
Listing expiration: 2026-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
66Y330CJHS	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 12 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1809414	Internal RxNorm lookup
1809421	Internal RxNorm lookup
1809434	Internal RxNorm lookup
1809438	Internal RxNorm lookup
1809444	Internal RxNorm lookup
1809539	Internal RxNorm lookup
1809665	Internal RxNorm lookup
1809667	Internal RxNorm lookup
1809668	Internal RxNorm lookup
1809670	Internal RxNorm lookup
1809671	Internal RxNorm lookup
1809672	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
9d42adca-0dd7-4df7-864d-5a7feee52130	Available on FDA.report

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
125105	Gammagard Liquid	Immune Globulin Infusion (Human)	351(a)	Rx	2026-10-01

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
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	Marketing start	Marketing end	Sample	Exclude flag	Status
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

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