Posaconazole NDC 0527-2133

NDC codes

FDA NDC Directory

Product NDC (as listed)0527-2133Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00527-2133Add 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
0527-2133-30	00527213330	24 TABLET, DELAYED RELEASE in 1 CARTON (0527-2133-30)Marketed from Jan 31, 2021
0527-2133-35	00527213335	60 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-35)Marketed from Aug 28, 2019
0527-2133-43	00527213343	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (0527-2133-43)Marketed from Aug 28, 2019

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Lannett Company Inc.
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 0527-2133_291b0655-036f-4073-a475-c33a411db178SPL ID 291b0655-036f-4073-a475-c33a411db178SPL set ID 94a9b028-a2bc-4f41-884d-2d6c536881fcRxCUI 1482908UNII 6TK1G07BHZUPC 0305272133358
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

N400527213330 followed by a unit qualifier and the quantity

Package 00527-2133-30. 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 3, 2024.

Indications (excerpt from the label)

Posaconazole delayed-release tablets is 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) o Posaconazole delayed-release tablets: adults and pediatric patients 2 years of age and older who weigh greater than 40 kg 1.2 Prophylaxis of Invasive Aspergillus and Candida Infections Posaco…

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
Posaconazoleposaconazole delayed-release	Posaconazole 100 mg/1	TabletOral	Chartwell RX, LLC	62135-429
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