NDC codes

FDA NDC Directory
Product NDC (as listed)67457-665Labeler and product segments. Claims need a package NDC.
Product NDC at billing width67457-0665Add 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
67457-665-2067457066520674570665201 VIAL, GLASS in 1 CARTON (67457-665-20) / 16.7 mL in 1 VIAL, GLASSMarketed from Mar 22, 2024

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 — 18 mg/mL
Dosage form
Solution
Route
Intravenous
Labeler
Mylan Institutional LLCNDC labeler code 67457
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 211500
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 67457-665_487860b5-2b62-4fef-9a89-8d4e8b4d7f63SPL ID 487860b5-2b62-4fef-9a89-8d4e8b4d7f63SPL set ID 1ebbd88b-547b-4b49-ab73-98094a2d5a79RxCUI 1492043UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

Administration

Drug administration (CPT 96360–96549)

When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.

How CPT relates to drug billing

NDC on a medical claim

N467457066520 followed by a unit qualifier and the quantity

Package 67457-0665-20. 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 is an azole antifungal indicated as follows: • Posaconazole is indicated for the treatment of invasive aspergillosis as follows: ( 1.1 ) o Posaconazole injection : adults and pediatric patients 2 years of age and older who weigh 10 kg or greater. • 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 injection : adults and…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 67457-665

What is NDC 67457-665?
67457-665 is the product NDC for posaconazole, Posaconazole 18 mg/mL solution, listed with the FDA by Mylan Institutional 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?
Mylan Institutional LLC, NDC labeler code 67457. 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
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
posaconazolePosaconazole 100 mg/1Tablet, CoatedOralNovadoz Pharmaceuticals LLC72205-16872205-0168-60
PosaconazolePosaconazole 18 mg/mLSolutionIntravenousCamber Pharmaceuticals, Inc.31722-37031722-0370-31
PosaconazolePosaconazole 100 mg/1Tablet, Delayed releaseOralAurobindo Pharma Limited59651-59659651-0596-60
posaconazolePosaconazole 18 mg/mLInjection, SolutionIntravenousGLENMARK PHARMACEUTICALS INC., USA68462-91168462-0911-01
PosaconazolePosaconazole 100 mg/1Tablet, Delayed releaseOralA2A Integrated Pharmaceuticals73141-02373141-0023-02
posaconazolePosaconazole 18 mg/mLInjection, SolutionIntravenousGLENMARK PHARMACEUTICALS INC., USA68462-90468462-0904-01
PosaconazolePosaconazole 18 mg/mLInjectionIntravenousEugia US LLC55150-38855150-0388-01
PosaconazolePosaconazole 18 mg/mLInjection, SolutionIntravenousFresensius Kabi USA, LLC63323-68563323-0685-17
posaconazolePosaconazole 18 mg/mLInjection, SolutionIntravenousGland Pharma Limited68083-57768083-0577-01
PosaconazolePosaconazole 100 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-266571335-2665-01

All 33 posaconazole NDCs

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