Gamunex-C

Product NDC: 13533-800
11-digit product format: 135330800
Labeler code: 13533
Product ID: 13533-800_8d03bd99-9ea6-4e20-b103-6a0a1fbcdce2
Type: PLASMA DERIVATIVE
Nonproprietary name: Immune Globulin (Human)
Dosage form: INJECTION
Route: INTRAVENOUS; SUBCUTANEOUS
Labeler: GRIFOLS USA, LLC
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

Additional Listing Data#

Finished product: Yes
Brand name base: Gamunex-C
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
13533-800-12	Gamunex-C	1 in 1 CARTON	INJECTION	1	37
13533-800-13	Gamunex-C	10 mL in 1 VIAL, GLASS	INJECTION	10	37
13533-800-15	Gamunex-C	1 in 1 CARTON	INJECTION	1	37
13533-800-16	Gamunex-C	25 mL in 1 VIAL, GLASS	INJECTION	25	37
13533-800-20	Gamunex-C	1 in 1 CARTON	INJECTION	1	37
13533-800-21	Gamunex-C	50 mL in 1 VIAL, GLASS	INJECTION	50	37
13533-800-24	Gamunex-C	1 in 1 CARTON	INJECTION	1	37
13533-800-25	Gamunex-C	200 mL in 1 VIAL, GLASS	INJECTION	200	37
13533-800-40	Gamunex-C	1 in 1 CARTON	INJECTION	1	37
13533-800-41	Gamunex-C	400 mL in 1 VIAL, GLASS	INJECTION	400	37
13533-800-71	Gamunex-C	1 in 1 CARTON	INJECTION	1	37
13533-800-72	Gamunex-C	100 mL in 1 VIAL, GLASS	INJECTION	100	37

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13533-800-12	ML - Milliliter	13533-800	df75549e-d5ff-4225-8b52-d51725b33022	1	2012-07-24
13533-800-13	ML - Milliliter	13533-800	b1372be0-70fe-4954-9871-4095466410c1	1	2014-01-04
13533-800-15	ML - Milliliter	13533-800	471c16ba-d38d-46c3-a135-7a8f407a0ded	1	2012-07-24
13533-800-16	ML - Milliliter	13533-800	8e0e046f-04a8-463e-b5bb-7bd4a1931c6e	1	2014-01-04
13533-800-20	ML - Milliliter	13533-800	cda8f47f-9295-49eb-811c-be05a22f635f	1	2012-07-24
13533-800-21	ML - Milliliter	13533-800	2b16c85b-1ab4-4ed4-84e1-2e7e3775955e	1	2014-01-04
13533-800-24	ML - Milliliter	13533-800	562b26f3-16fc-45b0-8c57-6f9eef215ad2	1	2012-07-24
13533-800-25	ML - Milliliter	13533-800	e2fb868d-7ed9-4abe-b4d9-9a0d08cac7a3	1	2013-08-02
13533-800-40	ML - Milliliter	13533-800	84a95c19-eb93-4fe4-a9f3-404c2e76beaa	1	2014-11-05
13533-800-41	ML - Milliliter	13533-800	bf43376d-03d9-4e35-930b-ce084d45e479	1	2014-11-05
13533-800-71	ML - Milliliter	13533-800	923e33f6-1219-411d-a0b3-a772f08e1e7c	1	2012-07-24
13533-800-72	ML - Milliliter	13533-800	be54eece-9bbc-4985-9eff-eb0b6fa40b00	1	2013-08-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Human Immunoglobulin G	ACTIVE INGREDIENT	66Y330CJHS	GAMUNEX-C (IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE CHROMATOGRAPHY PURIFIED) INJECTION [GRIFOLS USA, LLC]	24
Human Immunoglobulin G	ACTIVE MOIETY	66Y330CJHS	GAMUNEX-C (IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE CHROMATOGRAPHY PURIFIED) INJECTION [GRIFOLS USA, LLC]	24
Glycine	INACTIVE INGREDIENT	TE7660XO1C	GAMUNEX-C (IMMUNE GLOBULIN INTRAVENOUS (HUMAN), 10% CAPRYLATE CHROMATOGRAPHY PURIFIED) INJECTION [GRIFOLS USA, LLC]	24

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13533-800	GAMUNEX-C (IMMUNE GLOBULIN (HUMAN)) INJECTION [GRIFOLS USA, LLC]	37	Current NDC, Legacy NDC, 12 package rows	20220503_ade6b84a-e95b-0a49-3296-f56208fdf35b.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
1809580	gamunex-C 10 % in 10 mL Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809582	gamunex-C 10 % in 100 mL Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809583	gamunex-C 10 % in 200 mL Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809581	gamunex-C 10 % in 25 mL Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809584	gamunex-C 10 % in 400 mL Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809578	gamunex-C 10 % in 50 mL Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809434	immunoglobulin G, human 10 % in 10 ML Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809421	immunoglobulin G, human 10 % in 100 ML Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809444	immunoglobulin G, human 10 % in 200 ML Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809438	immunoglobulin G, human 10 % in 25 ML Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809524	immunoglobulin G, human 10 % in 400 ML Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809414	immunoglobulin G, human 10 % in 50 ML Injection	PSN	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809580	10 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]	SBD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809582	100 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]	SBD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809583	200 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]	SBD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809581	25 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]	SBD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809584	400 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]	SBD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809578	50 ML immunoglobulin G, human 100 MG/ML Injection [Gamunex]	SBD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809434	10 ML immunoglobulin G, human 100 MG/ML Injection	SCD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809421	100 ML immunoglobulin G, human 100 MG/ML Injection	SCD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809444	200 ML immunoglobulin G, human 100 MG/ML Injection	SCD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809438	25 ML immunoglobulin G, human 100 MG/ML Injection	SCD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809524	400 ML immunoglobulin G, human 100 MG/ML Injection	SCD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809414	50 ML immunoglobulin G, human 100 MG/ML Injection	SCD	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809580	10 ML Gamunex 100 MG/ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809582	100 ML Gamunex 100 MG/ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809583	200 ML Gamunex 100 MG/ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809581	25 ML Gamunex 100 MG/ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809584	400 ML Gamunex 100 MG/ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809578	50 ML Gamunex 100 MG/ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809580	Gamunex 10 % per 10 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809581	Gamunex 10 % per 25 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809578	Gamunex 10 % per 50 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809582	Gamunex 10 GM per 100 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809583	Gamunex 20 GM per 200 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809584	Gamunex 40 GM per 400 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809580	Gamunex-C 1 GM per 10 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809582	Gamunex-C 10 % per 100 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809583	Gamunex-C 10 % per 200 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809584	Gamunex-C 10 % per 400 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809581	Gamunex-C 2.5 GM per 25 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809578	Gamunex-C 5 GM per 50 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809434	immunoglobulin G, human 1 GM per 10 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809434	immunoglobulin G, human 10 % per 10 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809421	immunoglobulin G, human 10 % per 100 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809444	immunoglobulin G, human 10 % per 200 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809438	immunoglobulin G, human 10 % per 25 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809524	immunoglobulin G, human 10 % per 400 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809414	immunoglobulin G, human 10 % per 50 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809421	immunoglobulin G, human 10 GM per 100 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809438	immunoglobulin G, human 2.5 GM per 25 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809444	immunoglobulin G, human 20 GM per 200 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809524	immunoglobulin G, human 40 GM per 400 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37
1809414	immunoglobulin G, human 5 GM per 50 ML Injection	SY	ade6b84a-e95b-0a49-3296-f56208fdf35b	37

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
13533-800-12	13533080012	1 VIAL, GLASS in 1 CARTON (13533-800-12) / 10 mL in 1 VIAL, GLASS (13533-800-13)		2010-10-13	0000-00-00	No	No	Current
13533-800-13	13533080013	10 mL in 1 VIAL, GLASS	10 ml					Historical
13533-800-15	13533080015	1 VIAL, GLASS in 1 CARTON (13533-800-15) / 25 mL in 1 VIAL, GLASS (13533-800-16)		2010-10-13	0000-00-00	No	No	Current
13533-800-16	13533080016	25 mL in 1 VIAL, GLASS	25 ml					Historical
13533-800-20	13533080020	1 VIAL, GLASS in 1 CARTON (13533-800-20) / 50 mL in 1 VIAL, GLASS (13533-800-21)		2010-10-13	0000-00-00	No	No	Current
13533-800-21	13533080021	50 mL in 1 VIAL, GLASS	50 ml					Historical
13533-800-24	13533080024	1 VIAL, GLASS in 1 CARTON (13533-800-24) / 200 mL in 1 VIAL, GLASS (13533-800-25)		2010-10-13	0000-00-00	No	No	Current
13533-800-25	13533080025	200 mL in 1 VIAL, GLASS	200 ml					Historical
13533-800-40	13533080040	1 VIAL, GLASS in 1 CARTON (13533-800-40) / 400 mL in 1 VIAL, GLASS (13533-800-41)		2010-10-13	0000-00-00	No	No	Current
13533-800-41	13533080041	400 mL in 1 VIAL, GLASS	400 ml					Historical
13533-800-71	13533080071	1 VIAL, GLASS in 1 CARTON (13533-800-71) / 100 mL in 1 VIAL, GLASS (13533-800-72)		2010-10-13	0000-00-00	No	No	Current
13533-800-72	13533080072	100 mL in 1 VIAL, GLASS	100 ml					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Gamunex-C	GRIFOLS USA, LLC \| GRIFOLS THERAPEUTICS LLC \| GRIFOLS BIOLOGICALS LLC	2022-04-29	PLASMA DERIVATIVE	37

Gamunex-C

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#