Prescription drug · NDA
Rytelo (imetelstat sodium) NDC 82959-112
Imetelstat sodium 47 mg/1 · Injection, Powder, Lyophilized, For solution · Intravenous · Geron Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82959-112-01 | 82959011201 | 1 VIAL, SINGLE-DOSE in 1 CARTON (82959-112-01) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSEMarketed from Jun 6, 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)
- Rytelo
- Generic name (nonproprietary)
- imetelstat sodium
- Active ingredients
- Imetelstat sodium — 47 mg/1
- Dosage form
- Injection, Powder, Lyophilized, For solution
- Route
- Intravenous
- Labeler
- Geron Corporation
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217779
- Marketing start
- Listing expires
- Other FDA classes
- Oligonucleotide Telomerase Inhibitors (Mechanism)
- Identifiers
- Product ID 82959-112_b96b0022-c4f5-458e-aa7e-21c62ac5cd8cSPL ID b96b0022-c4f5-458e-aa7e-21c62ac5cd8cSPL set ID b0fab7ca-e578-43c5-9df6-bdaff4182257RxCUI 2685241, 2685246, 2685248, 2685250UNII 2AW48LAZ4I
- Pharmacologic class
- Oligonucleotide Telomerase 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N482959011201followed by a unit qualifier and the quantityPackage 82959-0112-01. 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)
1. INDICATIONS AND USAGE RYTELO is indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating agents (ESA). RYTELO is an oligonucleotide telomerase inhibitor indicated for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (MDS) with transfusion-dependent anemia requiring 4 or more red blood cell units over 8 weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-stimulating age…
Excerpt only. Read the full label for complete information.