NDC 13533-800
Gamunex-C
Immune Globulin (human)
Gamunex-C is a Intravenous; Subcutaneous Injection in the Plasma Derivative category. It is labeled and distributed by Grifols Usa, Llc. The primary component is Human Immunoglobulin G.
| Product ID | 13533-800_44f9a8a7-5292-46e9-ab81-9c0a5265d58b |
| NDC | 13533-800 |
| Product Type | Plasma Derivative |
| Proprietary Name | Gamunex-C |
| Generic Name | Immune Globulin (human) |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS; SUBCUTANEOUS |
| Marketing Start Date | 2010-10-13 |
| Marketing Category | BLA / BLA |
| Application Number | BLA125046 |
| Labeler Name | GRIFOLS USA, LLC |
| Substance Name | HUMAN IMMUNOGLOBULIN G |
| Active Ingredient Strength | 10 g/100mL |
| Pharm Classes | Human Immunoglobulin G [EPC],Passively Acquired Immunity [PE],Antigen Neutralization [MoA],Immunoglobulins [CS] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2021-12-31 |
Packaging
NDC 13533-800-12
1 VIAL, GLASS in 1 CARTON (13533-800-12) > 10 mL in 1 VIAL, GLASS (13533-800-13)
| Marketing Start Date | 2010-10-13 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 13533-800-21 [13533080021]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-07 |
NDC 13533-800-40 [13533080040]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2014-09-16 |
NDC 13533-800-13 [13533080013]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-07 |
NDC 13533-800-15 [13533080015]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 13533-800-20 [13533080020]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 13533-800-72 [13533080072]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-07 |
NDC 13533-800-41 [13533080041]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2014-09-16 |
NDC 13533-800-12 [13533080012]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 13533-800-25 [13533080025]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-07 |
NDC 13533-800-16 [13533080016]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2012-11-07 |
NDC 13533-800-71 [13533080071]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
NDC 13533-800-24 [13533080024]
Gamunex-C INJECTION
| Marketing Category | BLA |
| Application Number | BLA125046 |
| Product Type | PLASMA DERIVATIVE |
| Billing Unit | ML |
| Marketing Start Date | 2010-10-13 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 10 g/100mL |
Pharmacological Class
- Human Immunoglobulin G [EPC]
- Passively Acquired Immunity [PE]
- Antigen Neutralization [MoA]
- Immunoglobulins [CS]
NDC Crossover Matching brand name "Gamunex-C" or generic name "Immune Globulin (human)"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 13533-800 | Gamunex-C | Immune Globulin (Human) |
| 61953-0004 | Flebogamma | Immune Globulin (Human) |
| 13533-335 | GamaSTAN | immune globulin (human) |
| 13533-635 | GAMASTAN | IMMUNE GLOBULIN (HUMAN) |
| 76125-900 | GAMMAKED | Immune Globulin (Human) |
Trademark Results [Gamunex-C]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GAMUNEX-C 85011751 3979311 Dead/Cancelled |
GRIFOLS THERAPEUTICS LLC 2010-04-12 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.