Prescription drug · NDA
Daurismo (glasdegib) NDC 0069-0298
Glasdegib 25 mg/1 · Tablet, Film coated · Oral · Pfizer Laboratories Div Pfizer Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0069-0298-60 | 00069029860 | 60 TABLET, FILM COATED in 1 BOTTLE (0069-0298-60)Marketed from Dec 10, 2018 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Daurismo
- Generic name (nonproprietary)
- glasdegib
- Active ingredients
- Glasdegib — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210656
- Marketing start
- Listing expires
- Other FDA classes
- Smoothened Receptor Antagonists (Mechanism)
- Identifiers
- Product ID 0069-0298_e850e390-b32e-4382-a2c7-d480c41bd3a6SPL ID e850e390-b32e-4382-a2c7-d480c41bd3a6SPL set ID 204a6f7e-c9a4-472b-abd2-9527bda64d17RxCUI 2105850, 2105856, 2105858, 2105860UNII K673DMO5H9UPC 0300690298603, 0300691531303
- Pharmacologic class
- Hedgehog Pathway 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
N400069029860followed by a unit qualifier and the quantityPackage 00069-0298-60. 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)
DAURISMO is indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. DAURISMO is a hedgehog pathway inhibitor indicated, in combination with low-dose cytarabine, for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 210656
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Daurismoglasdegib | Glasdegib 100 mg/1 | Tablet, Film coatedOral | Pfizer Laboratories Div Pfizer Inc | 0069-1531 |