What is NDC 50458-290?

50458-290 is the product NDC for Sporanox (itraconazole), Itraconazole 100 mg/1 capsule, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Sporanox?

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.

Sporanox NDC 50458-290 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50458-290Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50458-0290Add 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
50458-290-01	50458029001	3 BLISTER PACK in 1 CARTON (50458-290-01) / 10 CAPSULE in 1 BLISTER PACKMarketed from Sep 11, 1992
50458-290-04	50458029004	30 CAPSULE in 1 BOTTLE (50458-290-04)Marketed from Sep 11, 1992

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): Sporanox
Generic name (nonproprietary): itraconazole
Active ingredients: Itraconazole — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Janssen Pharmaceuticals, Inc.NDC labeler code 50458
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 020083
Marketing start: Sep 11, 1992
Marketing end: Nov 30, 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 50458-290_a79c080b-711a-4a15-af92-ff0c60cbfdf1SPL ID a79c080b-711a-4a15-af92-ff0c60cbfdf1SPL set ID a4d555fa-787c-40fb-bb7d-b0d4f7318fd0RxCUI 311204, 833164UNII 304NUG5GF4UPC 0350458290042
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

N450458029001 followed by a unit qualifier and the quantity

Package 50458-0290-01. 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 Jul 13, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE SPORANOX ® (itraconazole) Capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised 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 t…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50458-290

What is NDC 50458-290?: 50458-290 is the product NDC for Sporanox (itraconazole), Itraconazole 100 mg/1 capsule, listed with the FDA by Janssen Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Sporanox (Itraconazole).
What is the active ingredient?: Itraconazole.
Who is the labeler?: Janssen Pharmaceuticals, Inc., NDC labeler code 50458. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Sporanox?: 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.

Other NDCs under NDA 020083

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

FDA NDC Directory listings under NDA 020083
Product	Strength	Form · route	Labeler	Product NDC
itraconazole	Itraconazole 100 mg/1	CapsuleOral	Patriot Pharmaceuticals	10147-1700

Sporanox (Itraconazole) NDC 50458-290