Xolair
- Product NDC
- 50242-227
- 11-digit product format
- 502420227
- Labeler code
- 50242
- Product ID
- 50242-227_e633fdb6-7fbc-4072-93ed-4e30abc6c3a1
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- omalizumab
- Dosage form
- INJECTION, SOLUTION
- Route
- SUBCUTANEOUS
- Labeler
- Genentech, Inc.
- Application
- BLA103976
- Marketing category
- BLA
- Marketing start
- 2023-08-18
- Substance
- OMALIZUMAB
- Active strength
- 300 mg/2mL
- Pharmacologic classes
- Anti-IgE [EPC], Decreased IgE Activity [PE], IgE-directed Antibody Interactions [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| 2P471X1Z11 | OMALIZUMAB | 242138-07-4 | OMALIZUMAB |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 50242-227-01 | 50242022701 | 1 SYRINGE, GLASS in 1 CARTON (50242-227-01) / 2 mL in 1 SYRINGE, GLASS | 2023-08-18 | No | No | Historical |
| 50242-227-55 | 50242022755 | 1 SYRINGE, GLASS in 1 CARTON (50242-227-55) / 2 mL in 1 SYRINGE, GLASS | 2023-08-18 | No | No | Historical |
| 50242-227-86 | 50242022786 | 1 SYRINGE, GLASS in 1 CARTON (50242-227-86) / 2 mL in 1 SYRINGE, GLASS | 2023-08-18 | Yes | No | Historical |
| 50242-227-99 | 50242022799 | 1 SYRINGE, GLASS in 1 CARTON (50242-227-99) / 2 mL in 1 SYRINGE, GLASS | 2023-08-18 | Yes | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| XOLAIR | Genentech, Inc. | Roche Diagnostics GmbH | 2025-12-02 | HUMAN PRESCRIPTION DRUG LABEL | 31 |