Prescription drug · NDA
Imkeldi (Imatinib oral) NDC 81927-201
Imatinib mesylate 80 mg/mL · Solution · Oral · Shorla Oncology Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81927-201-01 | 8192702010181927020101 | 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.,NDC labeler code 81927
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 219097
- Marketing start
- Listing expires
- 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
N481927020101followed by a unit qualifier and the quantityPackage 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Imkeldi is a kinase inhibitor indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. ( 1.1 ) Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. ( 1.2 ) Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). ( 1.3 ) Pediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) in combination with chemotherapy. ( 1.4 ) Adult patien…
Excerpt only. Read the full label for complete information.
About NDC 81927-201
- What is NDC 81927-201?
- 81927-201 is the product NDC for Imkeldi (imatinib oral), Imatinib mesylate 80 mg/mL solution, listed with the FDA by Shorla Oncology Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Imkeldi (Imatinib oral).
- What is the active ingredient?
- Imatinib mesylate.
- Who is the labeler?
- Shorla Oncology Inc.,, NDC labeler code 81927. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Imkeldi?
- 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.