Prescription drug · BLA
Epkinly (Epcoritamab-bysp) NDC 82705-010
Epcoritamab 48 mg/.8mL · Injection, Solution · Subcutaneous · Genmab US, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82705-010-01 | 82705001001 | 1 VIAL, GLASS in 1 CARTON (82705-010-01) / .8 mL in 1 VIAL, GLASSMarketed from May 19, 2023 |
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)
- Epkinly
- Generic name (nonproprietary)
- epcoritamab-bysp
- Active ingredients
- Epcoritamab — 48 mg/.8mL
- Dosage form
- Injection, Solution
- Route
- Subcutaneous
- Labeler
- Genmab US, Inc.NDC labeler code 82705
- Product type
- Prescription drug
- Marketing category
- BLA — Biologics License ApplicationApplication BLA 761324
- Marketing start
- Listing expires
- Other FDA classes
- CD20-directed Antibody Interactions (Mechanism)CD3 Receptor Agonists (Mechanism)CD3-directed Antibody Interactions (Mechanism)Cytochrome P450 Inhibitors (Mechanism)Increased Cytokine Activity (Physiologic effect)
- Identifiers
- Product ID 82705-010_e2f39a72-c677-4ded-a10c-da739f457180SPL ID e2f39a72-c677-4ded-a10c-da739f457180SPL set ID d7836711-b677-412d-bf2d-0f7c8444103aRxCUI 2637399, 2637405, 2637408, 2637411UNII D6OMY2L0WA
- Pharmacologic class
- Bispecific CD20-directed CD3 T Cell Engager
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
N482705001001followed by a unit qualifier and the quantityPackage 82705-0010-01. 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)
EPKINLY is a bispecific CD20-directed CD3 T-cell engager indicated: For the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, and high-grade B-cell lymphoma after two or more lines of systemic therapy. ( 1.1 ) This indication is approved under accelerated approval based on response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). In combination with lenalidomide and rituximab for the treatment of adult patients with relapsed or refractory follicular lymph…
Excerpt only. Read the full label for complete information.
About NDC 82705-010
- What is NDC 82705-010?
- 82705-010 is the product NDC for Epkinly (epcoritamab-bysp), Epcoritamab 48 mg/.8mL injection, solution, listed with the FDA by Genmab US, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Epkinly (Epcoritamab-bysp).
- What is the active ingredient?
- Epcoritamab.
- Who is the labeler?
- Genmab US, Inc., NDC labeler code 82705. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Epkinly?
- 1 other product NDC are listed under this name. See all Epkinly NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Epkinly products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Epkinlyepcoritamab-bysp | Epcoritamab 4 mg/.8mL | Injection, SolutionSubcutaneous | Genmab US, Inc. | 82705-002 | 82705-0002-01 |
Other NDCs under BLA 761324
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 |
|---|---|---|---|---|
| Epkinlyepcoritamab-bysp | Epcoritamab 4 mg/.8mL | Injection, SolutionSubcutaneous | Genmab US, Inc. | 82705-002 |