What is NDC 65162-630?

65162-630 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 65162-630 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)65162-630Labeler and product segments. Claims need a package NDC.

Product NDC at billing width65162-0630Add 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
65162-630-03	65162063003	30 CAPSULE in 1 BOTTLE (65162-630-03)Marketed from Sep 27, 2016

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: Amneal Pharmaceuticals LLCNDC labeler code 65162
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 205080
Marketing start: Sep 27, 2016
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 65162-630_cf72da65-d17b-40fc-b5a8-02493d23643cSPL ID cf72da65-d17b-40fc-b5a8-02493d23643cSPL set ID 2ab38a8a-3708-4b97-9f7f-8e554a15348dRxCUI 311204UNII 304NUG5GF4UPC 0365162630039
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

N465162063003 followed by a unit qualifier and the quantity

Package 65162-0630-03. 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 Jul 22, 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 65162-630

What is NDC 65162-630?: 65162-630 is the product NDC for Itraconazole, Itraconazole 100 mg/1 capsule, listed with the FDA by Amneal Pharmaceuticals LLC. 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?: Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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	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 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	AvPAK	50268-450
Itraconazole	Itraconazole 100 mg/1	CapsuleOral	American Health Packaging	60687-299