NDC codes

FDA NDC Directory
Product NDC (as listed)59651-596Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0596Add 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
59651-596-60596510596605965105966060 TABLET, DELAYED RELEASE in 1 BOTTLE (59651-596-60)Marketed from Jul 18, 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 — 100 mg/1
Dosage form
Tablet, Delayed release
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217119
Marketing start
Listing expires
Other FDA classes
Azoles (Chemical structure)
Identifiers
Product ID 59651-596_c54279d9-ce17-4213-8db5-eee9bc63ea34SPL ID c54279d9-ce17-4213-8db5-eee9bc63ea34SPL set ID f8a26673-261c-4e8e-b1e1-9e23aaf7f285RxCUI 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

N459651059660 followed by a unit qualifier and the quantity

Package 59651-0596-60. 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 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 ) 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 Posaconazole delayed-release ta…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-596

What is NDC 59651-596?
59651-596 is the product NDC for Posaconazole, Posaconazole 100 mg/1 tablet, delayed release, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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 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
PosaconazolePosaconazole 100 mg/1Tablet, Delayed releaseOralBryant Ranch Prepack71335-266571335-2665-01

All 33 Posaconazole NDCs

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