Prescription drug · ANDA
Oxymorphone Hydrochloride NDC 13107-104
Oxymorphone hydrochloride 10 mg/1 · Tablet · Oral · Aurolife Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13107-104-01 | 1310701040113107010401 | 100 TABLET in 1 BOTTLE (13107-104-01)Marketed from Apr 26, 2016 | |
| 13107-104-30 | 1310701043013107010430 | 30 TABLET in 1 BOTTLE (13107-104-30)Marketed from Apr 26, 2016 | |
| 13107-104-99 | 1310701049913107010499 | 1000 TABLET in 1 BOTTLE (13107-104-99)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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurolife Pharma, LLCNDC labeler code 13107
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204459
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 13107-104_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
N413107010401followed by a unit qualifier and the quantityPackage 13107-0104-01. 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 . 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.
About NDC 13107-104
- What is NDC 13107-104?
- 13107-104 is the product NDC for Oxymorphone Hydrochloride, Oxymorphone hydrochloride 10 mg/1 tablet, listed with the FDA by Aurolife Pharma, LLC. It has 3 package NDCs, 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?
- Aurolife Pharma, LLC, NDC labeler code 13107. 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.
Related NDCs: other Oxymorphone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 5 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-070 | 10702-0070-0110702-0070-06 |
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 10 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-071 | 10702-0071-0110702-0071-06 |
Other NDCs under ANDA 204459
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 5 mg/1 | TabletOral | Aurolife Pharma, LLC | 13107-103 |