What is NDC 50268-450?

50268-450 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.

AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Itraconazole?

11 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Itraconazole NDC 50268-450 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50268-450Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50268-0450Add 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
50268-450-12	50268045012	20 BLISTER PACK in 1 BOX, UNIT-DOSE (50268-450-12) / 1 CAPSULE in 1 BLISTER PACK (50268-450-11)Marketed from Mar 23, 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): Itraconazole
Generic name (nonproprietary): itraconazole
Active ingredients: Itraconazole — 100 mg/1
Dosage form: Capsule
Route: Oral
Labeler: AvPAKNDC labeler code 50268
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205080
Marketing start: Mar 23, 2018
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)Breast Cancer Resistance Protein Inhibitors (Mechanism)Cytochrome P450 3A4 Inhibitors (Mechanism)P-Glycoprotein Inhibitors (Mechanism)
Identifiers: Product ID 50268-450_4823fc2f-1a82-9e54-e063-6294a90abb18SPL ID 4823fc2f-1a82-9e54-e063-6294a90abb18SPL set ID 68165d90-953c-e2f5-e053-2a91aa0ada25RxCUI 311204UNII 304NUG5GF4
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

N450268045012 followed by a unit qualifier and the quantity

Package 50268-0450-12. 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 11, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE 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 the cultures a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50268-450

What is NDC 50268-450?: 50268-450 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by AvPAK. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Itraconazole.
What is the active ingredient?: Itraconazole.
Who is the labeler?: AvPAK, NDC labeler code 50268. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Itraconazole?: 11 other product NDCs are listed under this name. See all Itraconazole NDCs.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Itraconazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	Rising Pharma Holdings, Inc.	16571-245	16571-0245-03
Itraconazole	Itraconazole 10 mg/mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-006	31722-0006-31
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	Torrent Pharmaceuticals Limited	13668-463	13668-0463-0513668-0463-3013668-0463-37+1 more
Itraconazole	Itraconazole 100 mg/1	Capsule, Coated pelletsOral	NorthStar RxLLC	16714-743	16714-0743-0116714-0743-02
Itraconazole	Itraconazole 100 mg/1	Capsule, Coated pelletsOral	Ascend Laboratories, LLC	67877-454	67877-0454-0567877-0454-3067877-0454-84+1 more
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	American Health Packaging	60687-299	60687-0299-25
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	Alembic Pharmaceuticals Limited	46708-204	46708-0204-0446708-0204-1046708-0204-30+2 more
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	Alembic Pharmaceuticals Inc.	62332-204	62332-0204-0462332-0204-1062332-0204-30+2 more
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-630	65162-0630-03
Itraconazole	Itraconazole 10 mg/mL	SolutionOral	Amneal Pharmaceuticals LLC	65162-087	65162-0087-3465162-0087-74

All 12 Itraconazole NDCs

Other NDCs under ANDA 205080

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

FDA NDC Directory listings under ANDA 205080
Product	Strength	Form · route	Labeler	Product NDC
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	American Health Packaging	60687-299
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	Amneal Pharmaceuticals LLC	65162-630