Oxymorphone Hydrochloride NDC 0054-0284

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0284Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0284Add 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
0054-0284-25	00054028425	100 TABLET in 1 BOTTLE (0054-0284-25)Marketed from Sep 27, 2010

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): Oxymorphone Hydrochloride
Generic name (nonproprietary): oxymorphone hydrochloride
Active ingredients: Oxymorphone hydrochloride — 10 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Hikma Pharmaceuticals USA Inc.
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 090964
Marketing start: Sep 27, 2010
Listing expires: Dec 31, 2026
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 0054-0284_74519e3e-078f-42ea-882e-1df0eb0eaaeeSPL ID 74519e3e-078f-42ea-882e-1df0eb0eaaeeSPL set ID 3eb971cf-ab82-49f3-a46c-4d76a8ce599eRxCUI 977939, 977942UNII 5Y2EI94NBC
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

N400054028425 followed by a unit qualifier and the quantity

Package 00054-0284-25. 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 Dec 12, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Oxymorphone hydrochloride tablets are indicated for the management of acute 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 and persist over the course of therapy [see Warnings and Precautions ( 5.1 )], reserve opioid analgesics, including oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxymorphone hydrochloride is an opioid agonist indicated for the manag…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 090964

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

FDA NDC Directory listings under ANDA 090964
Product	Strength	Form · route	Labeler	Product NDC
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 5 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc.	0054-0283