NDC 55513-710 – Prolia
Denosumab 60 mg/mL · Injection · Subcutaneous
Product NDC55513-710
Product details
- Brand name
- Prolia
- Generic name
- denosumab
- Labeler
- Amgen, Inc
- Dosage form
- Injection
- Route
- Subcutaneous
- Marketing category
- BLA · BLA125320
- Marketed since
- June 5, 2010
- Listing expires
- December 31, 2027
- Pharmacologic class
- RANK Ligand Inhibitor
Active ingredients
- Denosumab 60 mg/mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 55513-710-01 | 1 SYRINGE in 1 CARTON (55513-710-01) / 1 mL in 1 SYRINGE | Jun 5, 2010 |
| 55513-710-21 | 1 SYRINGE in 1 CARTON (55513-710-21) / 1 mL in 1 SYRINGE | Mar 5, 2024 |
Recalls mentioning this NDC
- D-0538-2025 Jul 30, 2025 · Class II
CGMP Deviations; potential temperature excursions due to transit delays - D-66318-001 Nov 13, 2013 · Class II
Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination.