Prescription drug · NDA
Tibsovo (ivosidenib) NDC 72694-617
Ivosidenib 250 mg/1 · Tablet, Film coated · Oral · Servier Pharmaceutical LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72694-617-60 | 72694061760 | 1 BOTTLE in 1 CARTON (72694-617-60) / 60 TABLET, FILM COATED in 1 BOTTLEMarketed from Oct 19, 2021 |
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)
- Tibsovo
- Generic name (nonproprietary)
- ivosidenib
- Active ingredients
- Ivosidenib — 250 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Servier Pharmaceutical LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 211192
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 2C9 Inducers (Mechanism)Cytochrome P450 3A4 Inducers (Mechanism)Isocitrate Dehydrogenase 1 Inhibitors (Mechanism)
- Identifiers
- Product ID 72694-617_190606ed-cb7f-411b-8548-cc2f98e57819SPL ID 190606ed-cb7f-411b-8548-cc2f98e57819SPL set ID 65d254c0-67ad-42c4-b972-ad463b755b2dRxCUI 2049878, 2049884UNII Q2PCN8MAM6
- Pharmacologic class
- Isocitrate Dehydrogenase 1 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
N472694061760followed by a unit qualifier and the quantityPackage 72694-0617-60. 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
Current FDA label (SPL), effective . This label includes a boxed warning.
Indications (excerpt from the label)
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with: Newly Diagnosed Acute Myeloid Leukemia (AML) In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy ( 1.1 ). Relapsed or refractory AML For the treatment of adult patients with relapsed or refractory AML ( 1.2 ). Relapsed or refractory Myelodysplastic Syndromes (MDS) For the treatment of adult patients with relapsed or refractory myelodysplastic syndromes ( 1.3 ). Locally Advanced or Metastatic C…
Excerpt only. Read the full label for complete information.