What is NDC 65597-407?

65597-407 is the product NDC for Turalio (pexidartinib hydrochloride), Pexidartinib hydrochloride 125 mg/1 capsule, listed with the FDA by Daiichi Sankyo Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Turalio (Pexidartinib hydrochloride).

Daiichi Sankyo Inc., NDC labeler code 65597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Turalio?

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.

Turalio NDC 65597-407 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65597-407Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65597-0407Add 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
65597-407-20	65597040720	1 BOTTLE in 1 CARTON (65597-407-20) / 120 CAPSULE in 1 BOTTLEMarketed from Feb 1, 2023
65597-407-28	65597040728	1 BOTTLE in 1 CARTON (65597-407-28) / 28 CAPSULE in 1 BOTTLEMarketed from Feb 1, 2023

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): Turalio
Generic name (nonproprietary): pexidartinib hydrochloride
Active ingredients: Pexidartinib hydrochloride — 125 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Daiichi Sankyo Inc.NDC labeler code 65597
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 211810
Marketing start: Feb 1, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Colony Stimulating Factor Receptor Type 1 (CSF-1R) Inhibitors (Mechanism)Cytochrome P450 2B6 Inhibitors (Mechanism)Cytochrome P450 3A Inducers (Mechanism)Kinase Inhibitors (Mechanism)Tyrosine Kinase Inhibitors (Mechanism)UGT1A1 Inhibitors (Mechanism)
Identifiers: Product ID 65597-407_00774850-56e9-4fb9-85e8-586967a9a5f1SPL ID 00774850-56e9-4fb9-85e8-586967a9a5f1SPL set ID 7b0ec4bf-b2ac-49ee-96af-7740ad3f2e16RxCUI 2626397, 2626399UNII YS6WAI3XN7
Pharmacologic class: Kinase 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

N465597040720 followed by a unit qualifier and the quantity

Package 65597-0407-20. 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 Jan 16, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

TURALIO is indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. TURALIO is a kinase inhibitor indicated for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 65597-407

What is NDC 65597-407?: 65597-407 is the product NDC for Turalio (pexidartinib hydrochloride), Pexidartinib hydrochloride 125 mg/1 capsule, listed with the FDA by Daiichi Sankyo Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Turalio (Pexidartinib hydrochloride).
What is the active ingredient?: Pexidartinib hydrochloride.
Who is the labeler?: Daiichi Sankyo Inc., NDC labeler code 65597. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Turalio?: 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.

Turalio (Pexidartinib hydrochloride) NDC 65597-407