Prescription drug · ANDA
Oxymorphone Hydrochloride NDC 72865-131
Oxymorphone hydrochloride 10 mg/1 · Tablet · Oral · XLCare Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72865-131-01 | 7286501310172865013101 | 100 TABLET in 1 BOTTLE (72865-131-01)Marketed from May 6, 2020 |
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
- XLCare Pharmaceuticals, Inc.NDC labeler code 72865
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210175
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 72865-131_4fdf3b7e-f6ff-4d78-a928-c9d47c5bc9d9SPL ID 4fdf3b7e-f6ff-4d78-a928-c9d47c5bc9d9SPL set ID 1a1d5061-b62a-49fa-a5b2-4970f51416aeRxCUI 977939, 977942UNII 5Y2EI94NBCUPC 0372865131015, 0372865130018
- 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
N472865013101followed by a unit qualifier and the quantityPackage 72865-0131-01. 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 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, and misuse with opioids, even at recommended doses [see Warnings and Precautions (5.1)] , reserve oxymorphone hydrochloride tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics or opioid combination products]: Have not been tolerated, or are not expected to be tolerated, Have not provided adequate analgesia, or are not expected to provide adequate analgesia Oxymorphone hydrochloride tablets are an opioid agonist i…
Excerpt only. Read the full label for complete information.
About NDC 72865-131
- What is NDC 72865-131?
- 72865-131 is the product NDC for Oxymorphone Hydrochloride, Oxymorphone hydrochloride 10 mg/1 tablet, listed with the FDA by XLCare Pharmaceuticals, 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?
- XLCare Pharmaceuticals, Inc., NDC labeler code 72865. 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 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 |
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 10 mg/1 | TabletOral | KVK-Tech, Inc. | 10702-071 | 10702-0071-0110702-0071-06 |
Other NDCs under ANDA 210175
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 | Camber Pharmaceuticals, Inc | 31722-929 |
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals, Inc | 31722-930 |
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1926 |
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 5 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-130 |