Columvi
- Product NDC
- 50242-127
- 11-digit product format
- 502420127
- Labeler code
- 50242
- Product ID
- 50242-127_5e794f49-9344-4145-82e3-c2f7f96988c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Glofitamab
- Dosage form
- CONCENTRATE
- Route
- INTRAVENOUS
- Labeler
- Genentech, Inc.
- Application
- BLA761309
- Marketing category
- BLA
- Marketing start
- 2023-06-15
- Substance
- GLOFITAMAB
- Active strength
- 10 mg/10mL
- Pharmacologic classes
- Bispecific CD20-directed CD3 T Cell Engager [EPC], CD20-directed Antibody Interactions [MoA], CD3 Receptor Agonists [MoA], CD3-directed Antibody Interactions [MoA], Cytochrome P450 Inhibitors [MoA], Increased Cytokine Activity [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Columvi
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| GLOFITAMAB | 10 mg/10mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 50242-127-01 | Columvi | 1 in 1 CARTON | CONCENTRATE | 1 | | 7 |
| 50242-127-01 | Columvi | 10 mL in 1 VIAL, SINGLE-DOSE | CONCENTRATE | 10 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 50242-127 | COLUMVI (GLOFITAMAB) CONCENTRATE COLUMVI (GLOFITAMAB) SOLUTION, CONCENTRATE [GENENTECH, INC.] | 5 | Current NDC, 2 package rows | 20250108_3516e753-f064-4d30-9bd5-e3f2e143f75d.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-127-01 | 50242012701 | 1 VIAL, SINGLE-DOSE in 1 CARTON (50242-127-01) / 10 mL in 1 VIAL, SINGLE-DOSE | 2023-06-15 | No | No | Historical |