Imkeldi (imatinib oral) NDC 81927-201

NDC codes

FDA NDC Directory

Product NDC (as listed)81927-201Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81927-0201Add 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 NDC	11-digit (billing)	Package	Copy
81927-201-01	81927020101	140 mL in 1 BOTTLE (81927-201-01)Marketed from Dec 19, 2024

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): Imkeldi
Generic name (nonproprietary): imatinib oral
Active ingredients: Imatinib mesylate — 80 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Shorla Oncology Inc.,
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 219097
Marketing start: Dec 19, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Bcr-Abl Tyrosine Kinase Inhibitors (Mechanism)Cytochrome P450 2D6 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)
Identifiers: Product ID 81927-201_dead98c8-2ac0-4fe6-890a-cc8c92ddcffcSPL ID dead98c8-2ac0-4fe6-890a-cc8c92ddcffcSPL set ID 26658bb7-9ba1-a10e-e063-6394a90a172eRxCUI 2699831, 2699837UNII 8A1O1M485B
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

N481927020101 followed by a unit qualifier and the quantity

Package 81927-0201-01. 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

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