KEDBUMIN
- Product NDC
- 76179-025
- 11-digit product format
- 761790025
- Labeler code
- 76179
- Product ID
- 76179-025_f267b0e0-c204-493f-80d2-4aea7517c246
- Type
- PLASMA DERIVATIVE
- Nonproprietary name
- Albumin (Human)
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Kedrion S.p.A
- Application
- BLA125384
- Marketing category
- BLA
- Marketing start
- 2011-09-15
- Substance
- ALBUMIN HUMAN
- Active strength
- 12.5 g/50mL
- Pharmacologic classes
- Human Serum Albumin [EPC], Increased Intravascular Volume [PE], Increased Oncotic Pressure [PE], Osmotic Activity [MoA], Serum Albumin [Chemical/Ingredient]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KEDBUMIN
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ALBUMIN HUMAN | 12.5 g/50mL |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76179-025-01 | KEDBUMIN | 50 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 50 | | 17 |
| 76179-025-02 | KEDBUMIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 17 |
| 76179-025-03 | KEDBUMIN | 100 mL in 1 VIAL | INJECTION, SOLUTION | 100 | | 17 |
| 76179-025-04 | KEDBUMIN | 1 in 1 CARTON | INJECTION, SOLUTION | 1 | | 17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 76179-025 | KEDBUMIN (ALBUMIN (HUMAN)) INJECTION, SOLUTION [KEDRION S.P.A] | 16 | Current NDC, Legacy NDC, 4 package rows | 20230928_57bd6811-8619-11e0-9d78-0800200c9a66.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76179-025-01 | 76179002501 | 50 mL in 1 VIAL, GLASS | 50 ml | | | | | Historical |
| 76179-025-02 | 76179002502 | 1 VIAL, GLASS in 1 CARTON (76179-025-02) / 50 mL in 1 VIAL, GLASS (76179-025-01) | | 2011-09-15 | 0000-00-00 | No | No | Current |
| 76179-025-03 | 76179002503 | 100 mL in 1 VIAL | 100 ml | | | | | Historical |
| 76179-025-04 | 76179002504 | 1 VIAL in 1 CARTON (76179-025-04) / 100 mL in 1 VIAL (76179-025-03) | 1 vial | 2011-09-15 | 0000-00-00 | No | No | Current |