Prescription drug · NDA
Copiktra (Duvelisib) NDC 73116-225
Duvelisib 25 mg/1 · Capsule · Oral · Secura Bio, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 73116-225-28 | 73116022528 | 28 CAPSULE in 1 PACKAGE (73116-225-28)Marketed from Sep 25, 2018 | |
| 73116-225-56 | 73116022556 | 56 CAPSULE in 1 PACKAGE (73116-225-56)Marketed from Sep 28, 2018 |
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)
- Copiktra
- Generic name (nonproprietary)
- duvelisib
- Active ingredients
- Duvelisib — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Secura Bio, IncNDC labeler code 73116
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211155
- Marketing start
- Listing expires
- Identifiers
- Product ID 73116-225_30ff13f0-1e77-43de-99c9-c309834f1e63SPL ID 30ff13f0-1e77-43de-99c9-c309834f1e63SPL set ID e3c5ac56-e1f6-473a-bc73-687836534780RxCUI 2058514, 2058520, 2058523, 2058525UNII 610V23S0JI
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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N473116022528followed by a unit qualifier and the quantityPackage 73116-0225-28. 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)
COPIKTRA is indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of systemic therapy. Limitations of Use: COPIKTRA is not indicated or recommended for the treatment of any patients with CLL or SLL as initial or second line treatment due to an increased risk of treatment-related mortality. COPIKTRA is a kinase inhibitor indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines lines of systemic therapy. ( 1 ) Limitations of Use : COPIKTRA is not indicated …
Excerpt only. Read the full label for complete information.
About NDC 73116-225
- What is NDC 73116-225?
- 73116-225 is the product NDC for Copiktra (duvelisib), Duvelisib 25 mg/1 capsule, listed with the FDA by Secura Bio, Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Copiktra (Duvelisib).
- What is the active ingredient?
- Duvelisib.
- Who is the labeler?
- Secura Bio, Inc, NDC labeler code 73116. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Copiktra?
- 1 other product NDC are listed under this name. See all Copiktra NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Copiktra products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Copiktraduvelisib | Duvelisib 15 mg/1 | CapsuleOral | Secura Bio, Inc | 73116-215 | 73116-0215-2873116-0215-56 |
Other NDCs under NDA 211155
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 |
|---|---|---|---|---|
| Copiktraduvelisib | Duvelisib 15 mg/1 | CapsuleOral | Secura Bio, Inc | 73116-215 |