HEPARIN SODIUM | N017029 | FRESENIUS KABI USA LLC
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from BE Pharmaceuticals AG FDA-2022-P-2952 · 5 docket documents BE Pharmaceuticals AG submitted this citizen petition on October 18, 2022, requesting that the FDA determine whether Heparin sodium injection, 5000 USP Units/mL manufactured by Fresenius Kabi USA LLC and approved under NDA 017029 was withdrawn from sale for reasons related to safety or effectiveness | 505(q) | 2022-11-21 | Granted | BE Pharmaceuticals AG |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$7.62
per ml
Lowest NADAC/Unit
$1.20
per ml
Brand NDCs
0
Generic NDCs
6
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 63323091513HEPARIN SODIUM 20,000 UNIT/ML VIAL | $7.62 | ML | Generic | — | 2025-07-23 |
| 63323011805HEPARIN SODIUM 5,000 UNIT/0.5 ML SYRINGE | $5.90 | ML | Generic | — | 2026-05-20 |
| 63323054213HEPARIN SODIUM 10,000 UNIT/ML VIAL | $2.17 | ML | Generic | — | 2026-06-17 |
| 63323026206HEPARIN SODIUM 5,000 UNIT/ML VIAL | $1.20 | ML | Generic | — | 2026-06-17 |
| 63323026236HEPARIN SODIUM 5,000 UNIT/ML VIAL | $1.20 | ML | Generic | — | 2026-06-17 |
| 63323026226HEPARIN SODIUM 5,000 UNIT/ML VIAL | $1.20 | ML | Generic | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
No patent or exclusivity listings for this strength.