Prescription drug · NDA
Empaveli (pegcetacoplan) NDC 73606-010
Pegcetacoplan 1080 mg/20mL · Injection, Solution · Subcutaneous · Apellis Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73606-010-01 | 73606001001 | 1 VIAL in 1 CARTON (73606-010-01) / 20 mL in 1 VIALMarketed from May 14, 2021 |
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)
- Empaveli
- Generic name (nonproprietary)
- pegcetacoplan
- Active ingredients
- Pegcetacoplan — 1080 mg/20mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215014
- Marketing start
- Listing expires
- Other FDA classes
- Complement Inhibitors (Mechanism)
- Identifiers
- Product ID 73606-010_a2186f40-2a97-4599-a1a6-e479baa8c1d9SPL ID a2186f40-2a97-4599-a1a6-e479baa8c1d9SPL set ID c23d89e9-b00b-4520-e053-2995a90a95afRxCUI 2557386, 2557391UNII TO3JYR3BOU
- Pharmacologic class
- Complement 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
N473606001001followed by a unit qualifier and the quantityPackage 73606-0010-01. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
EMPAVELI is a complement inhibitor indicated: for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). ( 1.1 ) for the treatment of adult and pediatric patients aged 12 years and older with C3 glomerulopathy (C3G) or primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN), to reduce proteinuria and the loss of kidney function. ( 1.2 ) 1.1 Paroxysmal Nocturnal Hemoglobinuria EMPAVELI ® is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH). 1.2 C3 Glomerulopathy or Primary Immune-Complex Membranoproliferative Glomerulonephritis EMPAVELI ® is indicated for the treatment of adult and pediatric patients aged 12…
Excerpt only. Read the full label for complete information.