YIMMUGO
- Product NDC
- 70573-605
- Requested package NDC
- 70573-605-11
- 11-digit product format
- 705730605
- Labeler code
- 70573
- Product ID
- 70573-605_50fc5ef0-a92e-6bc0-e063-6294a90a1926
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- immune globulin intravenous, human - dira
- Dosage form
- SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Kedrion Biopharma Inc
- Application
- BLA125810
- Marketing category
- BLA
- Marketing start
- 2025-07-01
- 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
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
- YIMMUGO
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN IMMUNOGLOBULIN G | 10 g/100mL |
Purple Book Biologic Products#
BLA, Proprietary name, Proper name table| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|
| 125810 | YIMMUGO | immune globulin intravenous, human-dira | 351(a) | Rx | 2026-09-01 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70573-605-11 | 70573060511 | 1 VIAL, GLASS in 1 CARTON (70573-605-11) / 100 mL in 1 VIAL, GLASS (70573-605-12) | 2025-07-01 | No | No | Current |