What is NDC 51862-462?

51862-462 is the product NDC for Tolsura (itraconazole), Itraconazole 65 mg/1 capsule, gelatin coated, listed with the FDA by Mayne Pharma Commercial LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Mayne Pharma Commercial LLC, NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tolsura?

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.

Tolsura NDC 51862-462 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-462Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0462Add 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
51862-462-60	51862046260	60 CAPSULE, GELATIN COATED in 1 BOTTLE, PLASTIC (51862-462-60)Marketed from Dec 11, 2018

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): Tolsura
Generic name (nonproprietary): itraconazole
Active ingredients: Itraconazole — 65 mg/1
Dosage form: Capsule, Gelatin coated
Route: Oral
Labeler: Mayne Pharma Commercial LLCNDC labeler code 51862
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 208901
Marketing start: Dec 11, 2018
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 51862-462_2a3303f1-eee7-4c07-9532-e153be149369SPL ID 2a3303f1-eee7-4c07-9532-e153be149369SPL set ID 306352d1-9d5a-49ad-b72d-893b99546861RxCUI 2106642, 2106648UNII 304NUG5GF4UPC 0351862462605
Pharmacologic class: Azole Antifungal

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

N451862046260 followed by a unit qualifier and the quantity

Package 51862-0462-60. 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 Apr 23, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

TOLSURA is indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised adult patients: Blastomycosis, pulmonary and extrapulmonary Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and Aspergillosis, pulmonary and extrapulmonary, in patients who are intolerant of or who are refractory to amphotericin B therapy. Specimens for fungal cultures and other relevant laboratory studies (wet mount, histopathology, serology) should be obtained before therapy to isolate and identify causative organisms. Therapy may be instituted before the results of the cultures and other laboratory studies are…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51862-462

What is NDC 51862-462?: 51862-462 is the product NDC for Tolsura (itraconazole), Itraconazole 65 mg/1 capsule, gelatin coated, listed with the FDA by Mayne Pharma Commercial LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tolsura (Itraconazole).
What is the active ingredient?: Itraconazole.
Who is the labeler?: Mayne Pharma Commercial LLC, NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tolsura?: 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.

Tolsura (Itraconazole) NDC 51862-462