Prescription drug · BLA
Repatha (evolocumab) NDC 72511-501
Evolocumab 140 mg/mL · Injection, Solution · Subcutaneous · Amgen USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72511-501-01 | 72511050101 | 1 SYRINGE in 1 CARTON (72511-501-01) / 1 mL in 1 SYRINGEMarketed from Nov 24, 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)
- Repatha
- Generic name (nonproprietary)
- evolocumab
- Active ingredients
- Evolocumab — 140 mg/mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Amgen USA Inc.
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 125522
- Marketing start
- Listing expires
- Other FDA classes
- Monoclonal (Chemical structure)PCSK9 Inhibitors (Mechanism)
- Identifiers
- Product ID 72511-501_cc9027e7-c9f4-4cc1-ae70-d1a62f44dcf1SPL ID cc9027e7-c9f4-4cc1-ae70-d1a62f44dcf1SPL set ID cd61e902-166d-4aa6-9f3c-a18c1008d07eRxCUI 1665895, 1665900, 1665904, 1665906, 1801319, 1801322UNII LKC0U3A8NJUPC 0372511770018
- Pharmacologic class
- PCSK9 Inhibitor
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
N472511050101followed by a unit qualifier and the quantityPackage 72511-0501-01. 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)
REPATHA is indicated: To reduce the risk of major adverse cardiovascular (CV) events (CV death, myocardial infarction, stroke, unstable angina requiring hospitalization, or coronary revascularization) in adults at increased risk for these events. As an adjunct to diet and exercise to reduce low-density lipoprotein cholesterol (LDL-C) in: adults with hypercholesterolemia. adults and pediatric patients aged 10 years and older with heterozygous familial hypercholesterolemia (HeFH). adults and pediatric patients aged 10 years and older with homozygous familial hypercholesterolemia (HoFH). REPATHA is a PCSK9 (proprotein convertase subtilisin kexin type 9) inhibitor indicated: To reduce the risk o…
Excerpt only. Read the full label for complete information.
Other NDCs under BLA 125522
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 |
|---|---|---|---|---|
| Repathaevolocumab | Evolocumab 140 mg/mL | Injection, SolutionSubcutaneous | Amgen USA Inc. | 72511-760 |
| Repathaevolocumab | Evolocumab 140 mg/mL | Injection, SolutionSubcutaneous | Amgen USA Inc. | 72511-750 |
| Repathaevolocumab | Evolocumab 140 mg/mL | Injection, SolutionSubcutaneous | Amgen USA Inc. | 72511-143 |
| Repathaevolocumab | Evolocumab 140 mg/mL | Injection, SolutionSubcutaneous | Amgen USA Inc. | 72511-393 |