What is NDC 72065-003?

72065-003 is the product NDC for Recorlev (levoketoconazole), Levoketoconazole 150 mg/1 tablet, listed with the FDA by Xeris Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Xeris Pharmaceuticals, Inc., NDC labeler code 72065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Recorlev?

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.

Recorlev NDC 72065-003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72065-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72065-0003Add 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
72065-003-01	7206500030172065000301	50 TABLET in 1 BOTTLE (72065-003-01)Marketed from Dec 30, 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): Recorlev
Generic name (nonproprietary): levoketoconazole
Active ingredients: Levoketoconazole — 150 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Xeris Pharmaceuticals, Inc.NDC labeler code 72065
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 214133
Marketing start: Dec 30, 2021
Listing expires: Dec 31, 2027
Other FDA classes: Cytochrome P450 11A1 Inhibitors (Mechanism)Cytochrome P450 11B1 Inhibitors (Mechanism)Cytochrome P450 17A1 Inhibitors (Mechanism)Cytochrome P450 2B6 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)Multidrug and Toxin Extrusion Transporter 1 Inhibitors (Mechanism)Organic Cation Transporter 2 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 72065-003_e0c15c64-0299-410c-906d-81633be03375SPL ID e0c15c64-0299-410c-906d-81633be03375SPL set ID d4c5fead-bc4a-fb02-e053-2a95a90ae4fcRxCUI 2588848, 2588854UNII 2DJ8R0NT7KUPC 0372065003013
Pharmacologic class: Cortisol Synthesis 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

N472065000301 followed by a unit qualifier and the quantity

Package 72065-0003-01. 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 Mar 10, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

RECORLEV is indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative. Limitations of Use RECORLEV is not approved for the treatment of fungal infections. The safety and effectiveness of RECORLEV for the treatment of fungal infections have not been established. RECORLEV is a cortisol synthesis inhibitor indicated for the treatment of endogenous hypercortisolemia in adult patients with Cushing’s syndrome for whom surgery is not an option or has not been curative ( 1 ) Limitations of Use RECORLEV is not approved for the treatment of fungal infections ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72065-003

What is NDC 72065-003?: 72065-003 is the product NDC for Recorlev (levoketoconazole), Levoketoconazole 150 mg/1 tablet, listed with the FDA by Xeris Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Recorlev (Levoketoconazole).
What is the active ingredient?: Levoketoconazole.
Who is the labeler?: Xeris Pharmaceuticals, Inc., NDC labeler code 72065. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Recorlev?: 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.

Recorlev (Levoketoconazole) NDC 72065-003