NDC 50242-041 – Cathflo Activase
Alteplase 2.2 mg/2mL · Injection, Powder, Lyophilized, For Solution · Intravenous
Product NDC50242-041
Product details
- Brand name
- Cathflo Activase
- Generic name
- Alteplase
- Labeler
- Genentech, Inc.
- Dosage form
- Injection, Powder, Lyophilized, For Solution
- Route
- Intravenous
- Marketing category
- BLA · BLA103172
- Marketed since
- September 4, 2001
- Listing expires
- December 31, 2027
Active ingredients
- Alteplase 2.2 mg/2mL
Uses, dosage, side effects and warnings for Cathflo Activase →
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 50242-041-10 | 10 VIAL in 1 CARTON (50242-041-10) / 2 mL in 1 VIAL | Oct 14, 2019 |
| 50242-041-64 | 1 VIAL in 1 CARTON (50242-041-64) / 2 mL in 1 VIAL | Sep 4, 2001 |
Recalls mentioning this NDC
- D-0509-2024 Jun 5, 2024 · Class II
Lack of Assurance of Sterility: Deformed stoppers observed during filling operations for Cathflo Activase. - D-0476-2021 Jun 2, 2021 · Class II
CGMP Deviations: Intermittent exposure to temperature excursion during storage.