What is NDC 11797-110?

11797-110 is the product NDC for Duvyzat (givinostat), Givinostat 8.86 mg/mL suspension, listed with the FDA by Italfarmaco SPA. It has 1 package NDC, shown above in 10- and 11-digit form.

Italfarmaco SPA, NDC labeler code 11797. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Duvyzat?

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.

Duvyzat NDC 11797-110 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)11797-110Labeler and product segments. Claims need a package NDC.

Product NDC at billing width11797-0110Add 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 NDC	11-digit (billing)	Package	Copy
11797-110-02	11797011002	1 BOTTLE in 1 CARTON (11797-110-02) / 140 mL in 1 BOTTLE (11797-110-01)Marketed from Mar 21, 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): Duvyzat
Generic name (nonproprietary): givinostat
Active ingredients: Givinostat — 8.86 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Italfarmaco SPANDC labeler code 11797
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217865
Marketing start: Mar 21, 2024
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 3A4 Inhibitors (Mechanism)Histone Deacetylase Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)
Identifiers: Product ID 11797-110_23b3f0a7-bf0e-4221-a534-145f6c4ea8b7SPL ID 23b3f0a7-bf0e-4221-a534-145f6c4ea8b7SPL set ID 1a28a3db-7880-4ac2-a2f2-2b4e362aafb6RxCUI 2678894, 2678900UNII 5P60F84FBHUPC 0311797110019
Pharmacologic class: Histone Deacetylase 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

N411797011002 followed by a unit qualifier and the quantity

Package 11797-0110-02. 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 Nov 21, 2024.

Indications (excerpt from the label)

DUVYZAT is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. DUVYZAT is a histone deacetylase inhibitor indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients 6 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 11797-110

What is NDC 11797-110?: 11797-110 is the product NDC for Duvyzat (givinostat), Givinostat 8.86 mg/mL suspension, listed with the FDA by Italfarmaco SPA. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Duvyzat (Givinostat).
What is the active ingredient?: Givinostat.
Who is the labeler?: Italfarmaco SPA, NDC labeler code 11797. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Duvyzat?: 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.

Duvyzat (Givinostat) NDC 11797-110