FDA.reportPublic FDA data

GAMMAGARD Liquid ERC

Product NDC
0944-2705
11-digit product format
009442705
Labeler code
0944
Product ID
0944-2705_2332ff1f-1311-4aaa-9d76-9a011b3f7956
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
2025-07-14
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 ERC
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HUMAN IMMUNOGLOBULIN G100 mg/mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0944-2705-01GAMMAGARD Liquid ERC100 mL in 1 VIAL, GLASSINJECTION, SOLUTION1002
0944-2705-05GAMMAGARD Liquid ERC50 mL in 1 VIAL, GLASSINJECTION, SOLUTION502
0944-2705-10GAMMAGARD Liquid ERC1 in 1 CARTONINJECTION, SOLUTION12
0944-2705-50GAMMAGARD Liquid ERC1 in 1 CARTONINJECTION, SOLUTION12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2733847GAMMAGARD ERC 10 % in 100 ML InjectionPSN1341fd31-0754-47f0-a4d6-7255056b65412
2733845GAMMAGARD ERC 10 % in 50 ML InjectionPSN1341fd31-0754-47f0-a4d6-7255056b65412
1809421immunoglobulin G, human 10 % in 100 ML InjectionPSN1341fd31-0754-47f0-a4d6-7255056b65412
1809414immunoglobulin G, human 10 % in 50 ML InjectionPSN1341fd31-0754-47f0-a4d6-7255056b65412
2733847100 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard ERC]SBD1341fd31-0754-47f0-a4d6-7255056b65412
273384550 ML immunoglobulin G, human 100 MG/ML Injection [Gammagard ERC]SBD1341fd31-0754-47f0-a4d6-7255056b65412
1809421100 ML immunoglobulin G, human 100 MG/ML InjectionSCD1341fd31-0754-47f0-a4d6-7255056b65412
180941450 ML immunoglobulin G, human 100 MG/ML InjectionSCD1341fd31-0754-47f0-a4d6-7255056b65412
2733847100 ML Gammagard ERC 100 MG/ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
273384550 ML Gammagard ERC 100 MG/ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
2733847Gammagard ERC 10 % per 100 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
2733845Gammagard ERC 10 % per 50 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
2733847Gammagard ERC 10 GM per 100 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
2733845Gammagard ERC 5 GM per 50 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
1809421immunoglobulin G, human 10 % per 100 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
1809414immunoglobulin G, human 10 % per 50 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
1809421immunoglobulin G, human 10 GM per 100 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412
1809414immunoglobulin G, human 5 GM per 50 ML InjectionSY1341fd31-0754-47f0-a4d6-7255056b65412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0944-2705-0100944270501100 mL in 1 VIAL, GLASS100 mlHistorical
0944-2705-050094427050550 mL in 1 VIAL, GLASS50 mlHistorical
0944-2705-10009442705101 VIAL, GLASS in 1 CARTON (0944-2705-10) / 100 mL in 1 VIAL, GLASS (0944-2705-01) 2025-07-14NoNoCurrent
0944-2705-50009442705501 VIAL, GLASS in 1 CARTON (0944-2705-50) / 50 mL in 1 VIAL, GLASS (0944-2705-05) 2025-07-14NoNoCurrent