NDC codes

FDA NDC Directory
Product NDC (as listed)71274-170Labeler and product segments. Claims need a package NDC.
Product NDC at billing width71274-0170Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
71274-170-60712740170601 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

N471274017060 followed by a unit qualifier and the quantity

Package 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.

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