Oxymorphone Hydrochloride NDC 13107-103

NDC codes

FDA NDC Directory

Product NDC (as listed)13107-103Labeler and product segments. Claims need a package NDC.

Product NDC at billing width13107-0103Add 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
13107-103-01	13107010301	100 TABLET in 1 BOTTLE (13107-103-01)Marketed from Apr 26, 2016
13107-103-30	13107010330	30 TABLET in 1 BOTTLE (13107-103-30)Marketed from Apr 26, 2016
13107-103-99	13107010399	1000 TABLET in 1 BOTTLE (13107-103-99)Marketed from Apr 26, 2016

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): Oxymorphone Hydrochloride
Generic name (nonproprietary): oxymorphone hydrochloride
Active ingredients: Oxymorphone hydrochloride — 5 mg/1
Dosage form: Tablet
Route: Oral
Labeler: Aurolife Pharma, LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 204459
Marketing start: Apr 26, 2016
Listing expires: Dec 31, 2027
DEA schedule: CII
Other FDA classes: Full Opioid Agonists (Mechanism)
Identifiers: Product ID 13107-103_cca2aea2-3582-4917-9996-d6834de71db6SPL ID cca2aea2-3582-4917-9996-d6834de71db6SPL set ID 22c7652a-aa16-4fa8-89d9-517e69059068RxCUI 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

N413107010301 followed by a unit qualifier and the quantity

Package 13107-0103-01. 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 Jun 29, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Oxymorphone hydrochloride tablets is 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, and 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 tablets is an opioid agonist indicated for the m…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 204459

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

FDA NDC Directory listings under ANDA 204459
Product	Strength	Form · route	Labeler	Product NDC
Oxymorphone Hydrochloride	Oxymorphone hydrochloride 10 mg/1	TabletOral	Aurolife Pharma, LLC	13107-104