WinRho SDF
- Product NDC
- 49591-330
- 11-digit product format
- 495910330
- Labeler code
- 49591
- Product ID
- 49591-330_4f9ff973-1f8b-ab2d-e063-6294a90a353c
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN RHO(D) IMMUNE GLOBULIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR; INTRAVENOUS
- Labeler
- Kamada Ltd.
- Application
- BLA103649
- Marketing category
- BLA
- Marketing start
- 2023-08-01
- Substance
- HUMAN RHO(D) IMMUNE GLOBULIN
- Active strength
- 1500 [iU]/1.3mL
- Pharmacologic classes
- Endogenous 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
- WinRho SDF
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN RHO(D) IMMUNE GLOBULIN | 1500 [iU]/1.3mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 49591-330-11 | WinRho SDF | 1.3 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 1.3 | | 6 |
| 49591-330-51 | WinRho SDF | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49591-330 | WINRHO SDF (HUMAN RHO(D) IMMUNE GLOBULIN) INJECTION, SOLUTION [KAMADA LTD.] | 3 | Current NDC, 2 package rows | 20240529_fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1790512 | rho(D) immune globulin, human 15,000 UNT in 13 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790506 | rho(D) immune globulin, human 1500 UNT in 1.3 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790374 | rho(D) immune globulin, human 2500 UNT in 2.2 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790382 | rho(D) immune globulin, human 5000 UNT in 4.4 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790513 | WinRho 15,000 UNT in 13 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790508 | WinRho 1500 UNT in 1.3 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790379 | WinRho 2500 UNT in 2.2 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790383 | WinRho 5000 UNT in 4.4 ML Injection | PSN | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790508 | 1.3 ML Rho(D) immune globulin, human 1154 UNT/ML Injection [WinRho] | SBD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790513 | 13 ML Rho(D) immune globulin, human 1154 UNT/ML Injection [WinRho] | SBD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790379 | 2.2 ML Rho(D) immune globulin, human 1136 UNT/ML Injection [WinRho] | SBD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790383 | 4.4 ML Rho(D) immune globulin, human 1136 UNT/ML Injection [WinRho] | SBD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790506 | 1.3 ML Rho(D) immune globulin, human 1154 UNT/ML Injection | SCD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790512 | 13 ML Rho(D) immune globulin, human 1154 UNT/ML Injection | SCD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790374 | 2.2 ML Rho(D) immune globulin, human 1136 UNT/ML Injection | SCD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790382 | 4.4 ML Rho(D) immune globulin, human 1136 UNT/ML Injection | SCD | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790508 | 1.3 ML WinRho 1154 UNT/ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790513 | 13 ML WinRho 1154 UNT/ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790379 | 2.2 ML WinRho 1136 UNT/ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790383 | 4.4 ML WinRho 1136 UNT/ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790512 | rho(D) immune globulin, human 15,000 UNT per 13 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790506 | rho(D) immune globulin, human 1500 UNT per 1.3 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790374 | rho(D) immune globulin, human 2500 UNT per 2.2 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790382 | rho(D) immune globulin, human 5000 UNT per 4.4 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790513 | WinRho 15,000 UNT per 13 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790508 | WinRho 1500 UNT per 1.3 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790379 | WinRho 2500 UNT per 2.2 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
| 1790383 | WinRho 5000 UNT per 4.4 ML Injection | SY | fdb8ec91-f3ec-40c5-9337-23cc5bcc4c6e | 6 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 49591-330-11 | 49591033011 | 1.3 mL in 1 VIAL, GLASS | 1.3 ml | | | | Historical |
| 49591-330-51 | 49591033051 | 1 VIAL, GLASS in 1 CARTON (49591-330-51) / 1.3 mL in 1 VIAL, GLASS (49591-330-11) | | 2023-08-01 | No | No | Historical |