NDC codes

FDA NDC Directory
Product NDC (as listed)0406-7711Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00406-7711Add 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 NDC11-digit (billing)PackageCopy
0406-7711-600040677116060 TABLET, DELAYED RELEASE in 1 BOTTLE (0406-7711-60)Marketed from May 10, 2022

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
SpecGx LLC
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 212226
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 0406-7711_2432a708-a147-4b42-972c-a118b280d3acSPL ID 2432a708-a147-4b42-972c-a118b280d3acSPL set ID 8412398b-c696-4f12-ba3a-da74dc8dadafRxCUI 1482908UNII 6TK1G07BHZ
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

N400406771160 followed by a unit qualifier and the quantity

Package 00406-7711-60. 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 .

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 tabl…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212226

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

FDA NDC Directory listings under ANDA 212226
ProductStrengthForm · routeLabelerProduct NDC
PosaconazolePosaconazole 100 mg/1Tablet, Delayed releaseOralGolden State Medical Supply, Inc.51407-676

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