KEDRAB
- Product NDC
- 76125-150
- 11-digit product format
- 761250150
- Labeler code
- 76125
- Product ID
- 76125-150_11e6b9cf-25e9-7a79-e063-6394a90a9432
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- HUMAN RABIES VIRUS IMMUNE GLOBULIN
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR
- Labeler
- Kedrion Biopharma Inc.
- Application
- BLA125613
- Marketing category
- BLA
- Marketing start
- 2017-11-08
- Substance
- HUMAN RABIES VIRUS IMMUNE GLOBULIN
- Active strength
- 150 [iU]/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KEDRAB
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| HUMAN RABIES VIRUS IMMUNE GLOBULIN | 150 [iU]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76125-150-02 | KEDRAB | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 7 |
| 76125-150-03 | KEDRAB | 2 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 2 | | 7 |
| 76125-150-10 | KEDRAB | 1 in 1 BOX | INJECTION, SOLUTION | 1 | | 7 |
| 76125-150-11 | KEDRAB | 10 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76125-150 | KEDRAB (HUMAN RABIES VIRUS IMMUNE GLOBULIN) INJECTION, SOLUTION [KEDRION BIOPHARMA INC.] | 7 | Current NDC, Legacy NDC, 4 package rows | 20240223_53f2a23b-c479-4c24-8cab-ee7a33a2633e.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1992538 | KEDRAB 150 UNT/ML in 10 ML Injection | PSN | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1992536 | KEDRAB 150 UNT/ML in 2 ML Injection | PSN | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1652833 | rabies immune globulin, human 150 UNT/ML in 10 ML Injection | PSN | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1652827 | rabies immune globulin, human 150 UNT/ML in 2 ML Injection | PSN | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1992538 | 10 ML rabies immune globulin, human 150 UNT/ML Injection [Kedrab] | SBD | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1992536 | 2 ML rabies immune globulin, human 150 UNT/ML Injection [Kedrab] | SBD | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1652833 | 10 ML rabies immune globulin, human 150 UNT/ML Injection | SCD | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1652827 | 2 ML rabies immune globulin, human 150 UNT/ML Injection | SCD | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1992536 | 2 ML Kedrab 150 UNT/ML Injection | SY | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1992538 | Kedrab 150 UNT/ML per 10 ML Injection | SY | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1992536 | Kedrab 150 UNT/ML per 2 ML Injection | SY | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1652833 | rabies immune globulin, human 150 UNT/ML per 10 ML Injection | SY | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
| 1652827 | rabies immune globulin, human 150 UNT/ML per 2 ML Injection | SY | 53f2a23b-c479-4c24-8cab-ee7a33a2633e | 7 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76125-150-02 | 76125015002 | 1 VIAL, GLASS in 1 BOX (76125-150-02) / 2 mL in 1 VIAL, GLASS (76125-150-03) | | 2017-11-08 | 0000-00-00 | No | No | Current |
| 76125-150-03 | 76125015003 | 2 mL in 1 VIAL, GLASS | 2 ml | | | | | Historical |
| 76125-150-10 | 76125015010 | 1 VIAL, GLASS in 1 BOX (76125-150-10) / 10 mL in 1 VIAL, GLASS (76125-150-11) | | 2017-11-08 | 0000-00-00 | No | No | Current |
| 76125-150-11 | 76125015011 | 10 mL in 1 VIAL, GLASS | 10 ml | | | | | Historical |