NDC codes

FDA NDC Directory
Product NDC (as listed)0254-2045Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00254-2045Add 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
0254-2045-02002542045020025420450260 TABLET, COATED in 1 BOTTLE (0254-2045-02)Marketed from Aug 30, 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, Coated
Route
Oral
Labeler
ENDO USA, Inc.NDC labeler code 0254
Product type
Prescription drug
Marketing category
NDA authorized genericApplication NDA 205053
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 0254-2045_15fdf050-71cb-476f-a7ce-38c40262f381SPL ID 15fdf050-71cb-476f-a7ce-38c40262f381SPL set ID e031b632-8e57-4359-87bd-a5da02bdc55fRxCUI 665019, 1482908UNII 6TK1G07BHZUPC 0302542045021
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

N400254204502 followed by a unit qualifier and the quantity

Package 00254-2045-02. 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 .

Indications (excerpt from the label)

Posaconazole is an azole antifungal indicated as follows: Posaconazole delayed-release tablets are indicated for the treatment of invasive aspergillosis in adults and pediatric patients 2 years of age and older who weigh greater than 40 kg. ( 1.1 ) 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 …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0254-2045

What is NDC 0254-2045?
0254-2045 is the product NDC for Posaconazole, Posaconazole 100 mg/1 tablet, coated, listed with the FDA by ENDO USA, Inc.. 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?
ENDO USA, Inc., NDC labeler code 0254. 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/mLSolutionIntravenousMylan Institutional LLC67457-66567457-0665-20
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

All 33 Posaconazole NDCs

Other NDCs under NDA 205053

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

FDA NDC Directory listings under NDA 205053
ProductStrengthForm · routeLabelerProduct NDC
NoxafilposaconazolePosaconazole 100 mg/1Tablet, CoatedOralMerck Sharp & Dohme LLC0085-4324

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