What is NDC 16571-245?

16571-245 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 16571-245 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)16571-245Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16571-0245Add 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
16571-245-03	16571024503	30 CAPSULE in 1 BOTTLE (16571-245-03)Marketed from Feb 3, 2025

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: Rising Pharma Holdings, Inc.NDC labeler code 16571
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205724
Marketing start: Feb 3, 2025
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 16571-245_f6ed388e-1181-4911-897a-e3d68e8945e2SPL ID f6ed388e-1181-4911-897a-e3d68e8945e2SPL set ID 6df5ff94-47ba-4881-abb4-b321e35a6955RxCUI 311204UNII 304NUG5GF4UPC 0316571245031
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

N416571024503 followed by a unit qualifier and the quantity

Package 16571-0245-03. 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 Aug 18, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS & USAGE Itraconazole capsules are indicated for the treatment of the following fungal infections in immunocompromised and non-immunocompromised patients: 1. Blastomycosis, pulmonary and extrapulmonary 2. Histoplasmosis, including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis, and 3. 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 cul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 16571-245

What is NDC 16571-245?: 16571-245 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by Rising Pharma Holdings, Inc.. 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?: Rising Pharma Holdings, Inc., NDC labeler code 16571. 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 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	CapsuleOral	AvPAK	50268-450	50268-0450-12
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