Posaconazole (posaconazole delayed-release) NDC 62135-429

NDC codes

FDA NDC Directory

Product NDC (as listed)62135-429Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62135-0429Add 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
62135-429-60	62135042960	60 TABLET in 1 BOTTLE (62135-429-60)Marketed from Dec 12, 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): Posaconazole
Generic name (nonproprietary): posaconazole delayed-release
Active ingredients: Posaconazole — 100 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Chartwell RX, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 212411
Marketing start: Aug 28, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 62135-429_f043ffa5-9564-4a98-e053-2995a90af810SPL ID f043ffa5-9564-4a98-e053-2995a90af810SPL set ID f2baa339-75ff-4c03-8334-a88648f701f7RxCUI 1482908UNII 6TK1G07BHZUPC 0362135429607
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

N462135042960 followed by a unit qualifier and the quantity

Package 62135-0429-60. 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 Dec 20, 2022.

Indications (excerpt from the label)

Posaconazole delayed-release tablets is an azole antifungal agent indicated as follows: ( 1 ) 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 graftversushost 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 ) 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaconazole is in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212411

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

FDA NDC Directory listings under ANDA 212411
Product	Strength	Form · route	Labeler	Product NDC
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Lannett Company Inc.	0527-2133
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	ATLANTIC BIOLOGICALS CORP.	17856-2133
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	American Health Packaging	60687-523