Prescription drug · NDA
Joenja (Leniolisib) NDC 71274-170
Leniolisib phosphate 70 mg/1 · Tablet, Film coated · Oral · Pharming Healthcare Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71274-170-60 | 71274017060 | 1 BOTTLE, PLASTIC in 1 CARTON (71274-170-60) / 60 TABLET, FILM COATED in 1 BOTTLE, PLASTICMarketed from Mar 29, 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)
- Joenja
- Generic name (nonproprietary)
- leniolisib
- Active ingredients
- Leniolisib phosphate — 70 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Pharming Healthcare Inc.NDC labeler code 71274
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217759
- Marketing start
- Listing expires
- Other FDA classes
- Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 1A2 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)Phosphoinositide 3-Kinase delta Inhibitors (Mechanism)
- Identifiers
- Product ID 71274-170_c3177c44-1a5c-43a8-b0ae-5d5b2696cbafSPL ID c3177c44-1a5c-43a8-b0ae-5d5b2696cbaf
- 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
N471274017060followed by a unit qualifier and the quantityPackage 71274-0170-60. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 71274-170
- What is NDC 71274-170?
- 71274-170 is the product NDC for Joenja (leniolisib), Leniolisib phosphate 70 mg/1 tablet, film coated, listed with the FDA by Pharming Healthcare Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Joenja (Leniolisib).
- What is the active ingredient?
- Leniolisib phosphate.
- Who is the labeler?
- Pharming Healthcare Inc., NDC labeler code 71274. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Joenja?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.