What is NDC 0054-0284?

0054-0284 is the product NDC for Oxymorphone Hydrochloride, Oxymorphone hydrochloride 10 mg/1 tablet, 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 Oxymorphone Hydrochloride?

26 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

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	0005402842500054028425	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.NDC labeler code 0054
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 Jan 19, 2026. 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 managem…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0054-0284

What is NDC 0054-0284?: 0054-0284 is the product NDC for Oxymorphone Hydrochloride, Oxymorphone hydrochloride 10 mg/1 tablet, 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?: Oxymorphone Hydrochloride.
What is the active ingredient?: Oxymorphone hydrochloride.
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 Oxymorphone Hydrochloride?: 26 other product NDCs are listed under this name. See all Oxymorphone Hydrochloride 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 Oxymorphone Hydrochloride NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 5 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-130	72865-0130-01
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 10 mg/1	TabletOral	XLCare Pharmaceuticals, Inc.	72865-131	72865-0131-01
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 5 mg/1	TabletOral	Epic Pharma, LLC	42806-330	42806-0330-01
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 10 mg/1	TabletOral	Epic Pharma, LLC	42806-331	42806-0331-01
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 5 mg/1	TabletOral	Camber Pharmaceuticals, Inc	31722-929	31722-0929-01
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 10 mg/1	TabletOral	Camber Pharmaceuticals, Inc	31722-930	31722-0930-01
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 5 mg/1	TabletOral	Bryant Ranch Prepack	63629-1926	63629-1926-01
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 5 mg/1	TabletOral	Aurolife Pharma, LLC	13107-103	13107-0103-0113107-0103-3013107-0103-99
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 10 mg/1	TabletOral	Aurolife Pharma, LLC	13107-104	13107-0104-0113107-0104-3013107-0104-99
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 5 mg/1	TabletOral	KVK-Tech, Inc.	10702-070	10702-0070-0110702-0070-06

All 27 Oxymorphone Hydrochloride NDCs

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