NDC 50242-214 – Xolair PFS
Omalizumab 75 mg/.5mL · Injection, Solution · Subcutaneous
Product NDC50242-214
Product details
- Brand name
- Xolair PFS
- Generic name
- omalizumab
- Labeler
- Genentech, Inc.
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Marketing category
- BLA · BLA103976
- Marketed since
- September 28, 2018
- Listing expires
- December 31, 2027
- Pharmacologic class
- Anti-IgE
Active ingredients
- Omalizumab 75 mg/.5mL
Package NDC codes (4)
| Package NDC | Description | Since |
|---|---|---|
| 50242-214-03 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-03) / .5 mL in 1 SYRINGE, GLASS | Aug 18, 2023 |
| 50242-214-55 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-55) / .5 mL in 1 SYRINGE, GLASS | Aug 18, 2023 |
| 50242-214-83 sample | 1 SYRINGE, GLASS in 1 CARTON (50242-214-83) / .5 mL in 1 SYRINGE, GLASS | Aug 18, 2023 |
| 50242-214-99 | 1 SYRINGE, GLASS in 1 CARTON (50242-214-99) / .5 mL in 1 SYRINGE, GLASS | Aug 18, 2023 |
Recalls mentioning this NDC
- D-0571-2025 Aug 13, 2025 · Class II
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. - D-0572-2025 Aug 13, 2025 · Class II
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements. - D-0650-2021 Jul 14, 2021 · Class II
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Other Xolair PFS products
- 50242-215 Omalizumab 150 mg/mL · Injection, Solution · Genentech, Inc.