Prescription drug · BLA
Evenity (romosozumab-aqqg) NDC 55513-998
Romosozumab 105 mg/1.17mL · Injection, Solution · Subcutaneous · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-998-02 | 55513099802 | 2 SYRINGE, GLASS in 1 CARTON (55513-998-02) / 1.17 mL in 1 SYRINGE, GLASS (55513-998-01)Marketed from Jul 1, 2024 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Evenity
- Generic name (nonproprietary)
- romosozumab-aqqg
- Active ingredients
- Romosozumab — 105 mg/1.17mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Amgen, Inc
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761062
- Marketing start
- Listing expires
- Identifiers
- Product ID 55513-998_1b60403e-86c5-4694-8cb5-2fc19f46dc49SPL ID 1b60403e-86c5-4694-8cb5-2fc19f46dc49SPL set ID 471baba2-7154-4488-9891-0db2f46791e7RxCUI 2123184, 2123185, 2123190, 2123191UNII 3VHF2ZD92J
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N455513099802followed by a unit qualifier and the quantityPackage 55513-0998-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
EVENITY is a sclerostin inhibitor indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history of osteoporotic fracture, or multiple risk factors for fracture; or patients who have failed or are intolerant to other available osteoporosis therapy. ( 1 ) Limitations of Use: Limit duration of use to 12 monthly doses. If osteoporosis therapy remains warranted, continued therapy with an anti-resorptive agent should be considered. ( 1.2 ) 1.1 Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture EVENITY is indicated for the treatment of osteoporosis in postmenopausal women at high risk for fracture, defined as a history…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 761062
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.