YIMMUGO
- Product NDC
- 83372-605
- 11-digit product format
- 833720605
- Labeler code
- 83372
- Product ID
- 83372-605_50f8c921-beb0-c68b-e063-6294a90a8eb8
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- immune globulin intravenous, human - dira
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Biotest AG
- Application
- BLA125810
- Marketing category
- BLA
- Marketing start
- 2025-03-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- YIMMUGO
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| HUMAN IMMUNOGLOBULIN G | 10 g/100mL |
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 |
|---|---|---|---|---|---|---|
| 83372-605-01 | YIMMUGO | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 83372-605-02 | YIMMUGO | 50 mL in 1 VIAL, GLASS | SOLUTION | 50 | 6 | |
| 83372-605-11 | YIMMUGO | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 83372-605-12 | YIMMUGO | 100 mL in 1 VIAL, GLASS | SOLUTION | 100 | 6 | |
| 83372-605-21 | YIMMUGO | 1 in 1 CARTON | SOLUTION | 1 | 6 | |
| 83372-605-22 | YIMMUGO | 200 mL in 1 VIAL, GLASS | SOLUTION | 200 | 6 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 83372-605-01 | ML - Milliliter | 83372-605 | cc43c7b1-74df-45bf-9048-488db1e0e03c | 1 | 2025-10-14 |
| 83372-605-02 | ML - Milliliter | 83372-605 | e5873b7f-e40f-4428-9a44-f25030138584 | 1 | 2025-10-14 |
| 83372-605-11 | ML - Milliliter | 83372-605 | 225c05be-3e78-466d-af9b-07087f21a957 | 1 | 2025-10-14 |
| 83372-605-12 | ML - Milliliter | 83372-605 | 4314afc4-9ec2-40ba-98b8-9a543e68fc7a | 1 | 2025-10-14 |
| 83372-605-21 | ML - Milliliter | 83372-605 | 25be224d-c7ed-4b9a-9813-2387875d67bb | 1 | 2025-10-14 |
| 83372-605-22 | ML - Milliliter | 83372-605 | ff58bbc6-31a2-408f-8f23-5878f05cd33c | 1 | 2025-10-14 |
DailyMed Dashboard NDC Coverage#
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 2706395 | immune globulin intravenous (human) - dira 10 % in 100 ML Injection | PSN | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706397 | immune globulin intravenous (human) - dira 10 % in 200 ML Injection | PSN | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706386 | immune globulin intravenous (human) - dira 10 % in 50 ML Injection | PSN | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706396 | Yimmugo 10 % in 100 ML Injection | PSN | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706398 | Yimmugo 10 % in 200 ML Injection | PSN | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706393 | Yimmugo 10 % in 50 ML Injection | PSN | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706396 | 100 ML immune globulin intravenous (human) - dira 100 MG/ML Injection [Yimmugo] | SBD | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706398 | 200 ML immune globulin intravenous (human) - dira 100 MG/ML Injection [Yimmugo] | SBD | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706393 | 50 ML immune globulin intravenous (human) - dira 100 MG/ML Injection [Yimmugo] | SBD | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706395 | 100 ML immune globulin intravenous (human) - dira 100 MG/ML Injection | SCD | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706397 | 200 ML immune globulin intravenous (human) - dira 100 MG/ML Injection | SCD | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706386 | 50 ML immune globulin intravenous (human) - dira 100 MG/ML Injection | SCD | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706395 | 100 ML immune globulin intravenous (human) - dira 100 MG/ML Injection | SY | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706396 | 100 ML Yimmugo 100 MG/ML Injection | SY | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706398 | 200 ML Yimmugo 100 MG/ML Injection | SY | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706386 | 50 ML immune globulin intravenous (human) - dira 100 MG/ML Injection | SY | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
| 2706393 | 50 ML Yimmugo 100 MG/ML Injection | SY | 77aaac18-f2af-46c4-8f65-b15be1cec3c2 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 83372-605-01 | 83372060501 | 1 VIAL, GLASS in 1 CARTON (83372-605-01) / 50 mL in 1 VIAL, GLASS (83372-605-02) | 2025-03-01 | No | No | Historical | |
| 83372-605-02 | 83372060502 | 50 mL in 1 VIAL, GLASS | 50 ml | Historical | |||
| 83372-605-11 | 83372060511 | 1 VIAL, GLASS in 1 CARTON (83372-605-11) / 100 mL in 1 VIAL, GLASS (83372-605-12) | 2025-03-01 | No | No | Historical | |
| 83372-605-12 | 83372060512 | 100 mL in 1 VIAL, GLASS | 100 ml | Historical | |||
| 83372-605-21 | 83372060521 | 1 VIAL, GLASS in 1 CARTON (83372-605-21) / 200 mL in 1 VIAL, GLASS (83372-605-22) | 2025-03-01 | No | No | Historical | |
| 83372-605-22 | 83372060522 | 200 mL in 1 VIAL, GLASS | 200 ml | Historical |