What is NDC 72319-023?

72319-023 is the product NDC for Posaconazole, Posaconazole 100 mg/1 tablet, delayed release, listed with the FDA by i3 Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

i3 Pharmaceuticals, LLC, NDC labeler code 72319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Posaconazole?

32 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Posaconazole NDC 72319-023 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)72319-023Labeler and product segments. Claims need a package NDC.

Product NDC at billing width72319-0023Add 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
72319-023-02	7231900230272319002302	60 TABLET, DELAYED RELEASE in 1 BOTTLE (72319-023-02)Marketed from Sep 15, 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: i3 Pharmaceuticals, LLCNDC labeler code 72319
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 216488
Marketing start: Sep 15, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 72319-023_3249c585-7620-444f-e063-6294a90ae5acSPL ID 3249c585-7620-444f-e063-6294a90ae5acSPL set ID d5300d14-219d-4e1e-bfac-b413c40d6e3aRxCUI 1482908UNII 6TK1G07BHZUPC 0372319023026
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

N472319002302 followed by a unit qualifier and the quantity

Package 72319-0023-02. 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 Nov 29, 2024.

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 ) 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 invasive…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 72319-023

What is NDC 72319-023?: 72319-023 is the product NDC for Posaconazole, Posaconazole 100 mg/1 tablet, delayed release, listed with the FDA by i3 Pharmaceuticals, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Posaconazole.
What is the active ingredient?: Posaconazole.
Who is the labeler?: i3 Pharmaceuticals, LLC, NDC labeler code 72319. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Posaconazole?: 32 other product NDCs are listed under this name. See all Posaconazole 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 Posaconazole NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
posaconazole	Posaconazole 100 mg/1	Tablet, CoatedOral	Novadoz Pharmaceuticals LLC	72205-168	72205-0168-60
Posaconazole	Posaconazole 18 mg/mL	SolutionIntravenous	Camber Pharmaceuticals, Inc.	31722-370	31722-0370-31
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Aurobindo Pharma Limited	59651-596	59651-0596-60
posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-911	68462-0911-01
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	A2A Integrated Pharmaceuticals	73141-023	73141-0023-02
posaconazole	Posaconazole 18 mg/mL	SolutionIntravenous	Mylan Institutional LLC	67457-665	67457-0665-20
posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-904	68462-0904-01
Posaconazole	Posaconazole 18 mg/mL	InjectionIntravenous	Eugia US LLC	55150-388	55150-0388-01
Posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	Fresensius Kabi USA, LLC	63323-685	63323-0685-17
posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-577	68083-0577-01

All 33 Posaconazole NDCs

Other NDCs under ANDA 216488

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

FDA NDC Directory listings under ANDA 216488
Product	Strength	Form · route	Labeler	Product NDC
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-2665
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	71335-2930
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Bryant Ranch Prepack	72162-2243
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	A2A Integrated Pharmaceuticals	73141-023