oxycodone hydrochloride NDC 0054-0390

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0390Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0390Add 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
0054-0390-63	00054039063	500 mL in 1 BOTTLE (0054-0390-63)Marketed from Sep 4, 2014

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): oxycodone hydrochloride
Generic name (nonproprietary): oxycodone hydrochloride
Active ingredients: Oxycodone hydrochloride — 5 mg/5mL
Dosage form: Solution
Route: Oral
Labeler: Hikma Pharmceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204037
Marketing start: Sep 4, 2014
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0390_47e856d4-de7d-49aa-8671-d1b4a35bad4dSPL ID 47e856d4-de7d-49aa-8671-d1b4a35bad4dSPL set ID d8e87c66-f872-4e1d-9ade-ef11490af63bRxCUI 1049604UNII C1ENJ2TE6C
Pharmacologic class: Opioid Agonist

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

N400054039063 followed by a unit qualifier and the quantity

Package 00054-0390-63. 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 Jan 20, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Oxycodone Hydrochloride Oral Solution is indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions (5.2)] , and persist over the course of therapy, reserve opioid analgesics, including Oxycodone Hydrochloride Oral Solution, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone Hydrochloride Oral Solution is an opioid agonist in…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204037

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

FDA NDC Directory listings under ANDA 204037
Product	Strength	Form · route	Labeler	Product NDC
Oxycodone Hydrochloride	Oxycodone hydrochloride 5 mg/5mL	SolutionOral	American Health Packaging	60687-406