Prescription drug · NDA
Parsabiv (Etelcalcetide) NDC 55513-740
Etelcalcetide hydrochloride 2.5 mg/.5mL · Injection, Solution · Intravenous · Amgen, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55513-740-10 | 5551307401055513074010 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-10) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01)Marketed from Apr 3, 2017 | |
| 55513-740-20 | 5551307402055513074020 | 10 VIAL, SINGLE-DOSE in 1 CARTON (55513-740-20) / .5 mL in 1 VIAL, SINGLE-DOSE (55513-740-01)Marketed from Aug 1, 2025 |
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)
- Parsabiv
- Generic name (nonproprietary)
- etelcalcetide
- Active ingredients
- Etelcalcetide hydrochloride — 2.5 mg/.5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Amgen, IncNDC labeler code 55513
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208325
- Marketing start
- Listing expires
- Other FDA classes
- Increased Calcium-sensing Receptor Sensitivity (Mechanism)
- Identifiers
- Product ID 55513-740_52286976-a97a-4b77-b678-f40ab5aa7133SPL ID 52286976-a97a-4b77-b678-f40ab5aa7133SPL set ID cd270093-c6a8-4596-a4ab-e6aa0a2c8a0cRxCUI 1876127, 1876132, 1876135, 1876136, 1876137, 1876138UNII 72PT5993DUUPC 0355513742108, 0355513740104, 0355513741101
- Pharmacologic class
- Calcium-sensing Receptor Agonist
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
N455513074010followed by a unit qualifier and the quantityPackage 55513-0740-10. 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 .
Indications (excerpt from the label)
PARSABIV is indicated for the treatment of secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. PARSABIV is a calcium-sensing receptor agonist indicated for: Secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease (CKD) on hemodialysis. ( 1 ) Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with CKD who are not on hemodialysis and is not recommended for use in these populations. Limitations of Use: PARSABIV has not been studied in adult patients with parathyroid carcinoma, primary hyperparathyroidism, or with chronic kidney disease who a…
Excerpt only. Read the full label for complete information.
About NDC 55513-740
- What is NDC 55513-740?
- 55513-740 is the product NDC for Parsabiv (etelcalcetide), Etelcalcetide hydrochloride 2.5 mg/.5mL injection, solution, listed with the FDA by Amgen, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Parsabiv (Etelcalcetide).
- What is the active ingredient?
- Etelcalcetide hydrochloride.
- Who is the labeler?
- Amgen, Inc, NDC labeler code 55513. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Parsabiv?
- 2 other product NDCs are listed under this name. See all Parsabiv NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Parsabiv products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Parsabivetelcalcetide | Etelcalcetide hydrochloride 5 mg/mL | Injection, SolutionIntravenous | Amgen, Inc | 55513-741 | 55513-0741-1055513-0741-20 |
| Parsabivetelcalcetide | Etelcalcetide hydrochloride 10 mg/2mL | Injection, SolutionIntravenous | Amgen, Inc | 55513-742 | 55513-0742-1055513-0742-20 |
Other NDCs under NDA 208325
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Parsabivetelcalcetide | Etelcalcetide hydrochloride 5 mg/mL | Injection, SolutionIntravenous | Amgen, Inc | 55513-741 |
| Parsabivetelcalcetide | Etelcalcetide hydrochloride 10 mg/2mL | Injection, SolutionIntravenous | Amgen, Inc | 55513-742 |