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
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 |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 100 mg/mL |
DailyMed Product Concepts#
| 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 | Form | Quantity | Strength | 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#
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| 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 | 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 | License type | Status | Latest source |
|---|---|---|---|---|---|
| 125105 | Gammagard Liquid | Immune Globulin Infusion (Human) | 351(a) | Rx | 2026-09-01 |
DailyMed RxNorm Mappings#
| 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 | 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 |