Posaconazole NDC 16714-535

NDC codes

FDA NDC Directory

Product NDC (as listed)16714-535Labeler and product segments. Claims need a package NDC.

Product NDC at billing width16714-0535Add 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
16714-535-01	16714053501	60 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-535-01)Marketed from Apr 2, 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: NorthStar RxLLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 214321
Marketing start: Apr 2, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 16714-535_f00461e3-12cb-3905-e053-2a95a90a4e12SPL ID f00461e3-12cb-3905-e053-2a95a90a4e12SPL set ID 4de6d839-e4bd-405c-83c5-8efc6abd0829RxCUI 1482908UNII 6TK1G07BHZUPC 0316714535012
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

N416714053501 followed by a unit qualifier and the quantity

Package 16714-0535-01. 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 Dec 17, 2022.

Indications (excerpt from the label)

Posaconazole is an azole antifungal indicated as follows: • Posaconazole is 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 ) o 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 are indicated for the prophylaxis of invasi…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 214321

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

FDA NDC Directory listings under ANDA 214321
Product	Strength	Form · route	Labeler	Product NDC
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Camber Pharmaceuticals, Inc.	31722-677