What is NDC 69339-159?

69339-159 is the product NDC for Itraconazole Oral (itraconazole), Itraconazole 10 mg/mL solution, listed with the FDA by Natco Pharma USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

Itraconazole Oral (Itraconazole).

Natco Pharma USA LLC, NDC labeler code 69339. 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 Oral?

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.

Itraconazole Oral NDC 69339-159 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69339-159Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69339-0159Add 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
69339-159-17	6933901591769339015917	40 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (69339-159-17) / 10 mL in 1 CUP, UNIT-DOSE (69339-159-01)Marketed from Apr 25, 2022

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 Oral
Generic name (nonproprietary): itraconazole
Active ingredients: Itraconazole — 10 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Natco Pharma USA LLCNDC labeler code 69339
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212239
Marketing start: Apr 25, 2022
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 69339-159_2af07b39-fe93-4961-90cb-ed9c5e2f424dSPL ID 2af07b39-fe93-4961-90cb-ed9c5e2f424dSPL set ID da63870d-b426-4e49-9591-5bb51f962e66RxCUI 348506UNII 304NUG5GF4UPC 0369339159019
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

N469339015917 followed by a unit qualifier and the quantity

Package 69339-0159-17. 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 5, 2023. This label includes a boxed warning.

Indications (excerpt from the label)

INDICATIONS AND USAGE Itraconazole oral solution is indicated for the treatment of oropharyngeal and esophageal candidiasis. (See CLINICAL PHARMACOLOGY: Special Populations , WARNINGS , and ADVERSE REACTIONS: Post-marketing Experience for more information .)

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69339-159

What is NDC 69339-159?: 69339-159 is the product NDC for Itraconazole Oral (itraconazole), Itraconazole 10 mg/mL solution, listed with the FDA by Natco Pharma USA LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Itraconazole Oral (Itraconazole).
What is the active ingredient?: Itraconazole.
Who is the labeler?: Natco Pharma USA LLC, NDC labeler code 69339. 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 Oral?: 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 ANDA 212239

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

FDA NDC Directory listings under ANDA 212239
Product	Strength	Form · route	Labeler	Product NDC
Itraconazole	Itraconazole 10 mg/mL	SolutionOral	Camber Pharmaceuticals, Inc.	31722-006

Itraconazole Oral (Itraconazole) NDC 69339-159