Prescription drug · NDA
Jaypirca (Pirtobrutinib) NDC 0002-7026
Pirtobrutinib 100 mg/1 · Tablet, Coated · Oral · Eli Lilly and Company
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0002-7026-60 | 00002702660 | 60 TABLET, COATED in 1 BOTTLE (0002-7026-60)Marketed from Jan 27, 2023 | |
| 0002-7026-99 | 00002702699 | 30 TABLET, COATED in 1 BOTTLE (0002-7026-99)Marketed from Feb 15, 2023 · Sample package |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Jaypirca
- Generic name (nonproprietary)
- pirtobrutinib
- Active ingredients
- Pirtobrutinib — 100 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Eli Lilly and CompanyNDC labeler code 0002
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 216059
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Bruton's Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
- Identifiers
- Product ID 0002-7026_ef421dc8-11db-4e6c-9154-dc04782cb52cSPL ID ef421dc8-11db-4e6c-9154-dc04782cb52cSPL set ID bd551845-0878-49a4-860f-839b83f6b801RxCUI 2629343, 2629349, 2629351, 2629353UNII JNA39I7ZVB
- Pharmacologic class
- Kinase 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 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
N400002702660followed by a unit qualifier and the quantityPackage 00002-7026-60. 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)
JAYPIRCA ® is a kinase inhibitor indicated for the treatment of: Adult patients with relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a BTK inhibitor. ( 1.1 ). This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) who have previously been treated with a covalent BTK inhibitor. ( 1.2 ). 1.1 Mantle Cell Lymphoma JAYPIRCA ® is indicated for the treatment of adult patient…
Excerpt only. Read the full label for complete information.
About NDC 0002-7026
- What is NDC 0002-7026?
- 0002-7026 is the product NDC for Jaypirca (pirtobrutinib), Pirtobrutinib 100 mg/1 tablet, coated, listed with the FDA by Eli Lilly and Company. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Jaypirca (Pirtobrutinib).
- What is the active ingredient?
- Pirtobrutinib.
- Who is the labeler?
- Eli Lilly and Company, NDC labeler code 0002. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Jaypirca?
- 1 other product NDC are listed under this name. See all Jaypirca NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Jaypirca products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Jaypircapirtobrutinib | Pirtobrutinib 50 mg/1 | Tablet, CoatedOral | Eli Lilly and Company | 0002-6902 | 00002-6902-30 |
Other NDCs under NDA 216059
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 |
|---|---|---|---|---|
| Jaypircapirtobrutinib | Pirtobrutinib 50 mg/1 | Tablet, CoatedOral | Eli Lilly and Company | 0002-6902 |