Posaconazole NDC 42291-919

NDC codes

FDA NDC Directory

Product NDC (as listed)42291-919Labeler and product segments. Claims need a package NDC.

Product NDC at billing width42291-0919Add 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
42291-919-60	42291091960	60 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-919-60)Marketed from Apr 20, 2023

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): Posaconazole
Generic name (nonproprietary): posaconazole
Active ingredients: Posaconazole — 100 mg/1
Dosage form: Tablet, Delayed release
Route: Oral
Labeler: AvKARE
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216626
Marketing start: Apr 20, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 42291-919_48bf9c42-5b32-629b-e063-6394a90a80b2SPL ID 48bf9c42-5b32-629b-e063-6394a90a80b2SPL set ID f9c81d88-8e2c-fa53-e053-6394a90ac5c4RxCUI 1482908UNII 6TK1G07BHZUPC 0342291919600
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

N442291091960 followed by a unit qualifier and the quantity

Package 42291-0919-60. 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 19, 2026.

Indications (excerpt from the label)

Posaconazole delayed-release tablets are an azole antifungal indicated as follows: Posaconazole delayed-release tablets are indicated for the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised, such as hematopoietic stem cell transplant (HSCT) recipients with graft-versus-host disease (GVHD) or those with hematologic malignancies with prolonged neutropenia from chemotherapy as follows: (1.2) Posaconazole delayed-release tablets: adults and pediatric patients 13 years of age and older 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole delayed-release tablets…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 216626

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

FDA NDC Directory listings under ANDA 216626
Product	Strength	Form · route	Labeler	Product NDC
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Amneal Pharmaceuticals NY LLC	69238-1476