NDC codes

FDA NDC Directory
Product NDC (as listed)0069-0298Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00069-0298Add 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 NDC11-digit (billing)PackageCopy
0069-0298-600006902986060 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

N400069029860 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under NDA 210656

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 210656
ProductStrengthForm · routeLabelerProduct NDC
DaurismoglasdegibGlasdegib 100 mg/1Tablet, Film coatedOralPfizer Laboratories Div Pfizer Inc0069-1531

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Daurismo (glasdegib) NDC 0069-0298 | Med-Code