What is NDC 0054-0449?

0054-0449 is the product NDC for posaconazole, Posaconazole 40 mg/mL suspension, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

posaconazole NDC 0054-0449 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0449Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0449Add 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	Copy
0054-0449-49	0005404494900054044949	1 BOTTLE, GLASS in 1 CARTON (0054-0449-49) / 105 mL in 1 BOTTLE, GLASSMarketed from Mar 29, 2023

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 — 40 mg/mL
Dosage form: Suspension
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.NDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 208773
Marketing start: Mar 29, 2023
Listing expires: Dec 31, 2027
Other FDA classes: Azoles (Chemical structure)
Identifiers: Product ID 0054-0449_cf1fc2ce-44cf-47fa-abce-50b4050f4a3bSPL ID cf1fc2ce-44cf-47fa-abce-50b4050f4a3bSPL set ID 282ddea7-47d8-44e4-8806-169d7cafa951RxCUI 665019UNII 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

N400054044949 followed by a unit qualifier and the quantity

Package 00054-0449-49. 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 May 18, 2026.

Indications (excerpt from the label)

Posaconazole is an azole antifungal indicated as follows: • Posaconazole is indicated for the prophylaxis of invasive Aspergillus and Candida infections in adults and pediatric patients 13 years of age and older 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. ( 1.2 ) • Posaconazole oral suspension is indicated for the treatment of oropharyngeal candidiasis (OPC), including OPC refractory (rOPC) to itraconazole and/or fluconazole in adults and pediatric patients aged …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0449

What is NDC 0054-0449?: 0054-0449 is the product NDC for posaconazole, Posaconazole 40 mg/mL suspension, listed with the FDA by Hikma Pharmaceuticals 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?: Hikma Pharmaceuticals USA Inc., NDC labeler code 0054. 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
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
posaconazole	Posaconazole 100 mg/1	Tablet, CoatedOral	Novadoz Pharmaceuticals LLC	72205-168	72205-0168-60
Posaconazole	Posaconazole 18 mg/mL	SolutionIntravenous	Camber Pharmaceuticals, Inc.	31722-370	31722-0370-31
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	Aurobindo Pharma Limited	59651-596	59651-0596-60
posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-911	68462-0911-01
Posaconazole	Posaconazole 100 mg/1	Tablet, Delayed releaseOral	A2A Integrated Pharmaceuticals	73141-023	73141-0023-02
posaconazole	Posaconazole 18 mg/mL	SolutionIntravenous	Mylan Institutional LLC	67457-665	67457-0665-20
posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	GLENMARK PHARMACEUTICALS INC., USA	68462-904	68462-0904-01
Posaconazole	Posaconazole 18 mg/mL	InjectionIntravenous	Eugia US LLC	55150-388	55150-0388-01
Posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	Fresensius Kabi USA, LLC	63323-685	63323-0685-17
posaconazole	Posaconazole 18 mg/mL	Injection, SolutionIntravenous	Gland Pharma Limited	68083-577	68083-0577-01

All 33 posaconazole NDCs