Prescription drug · ANDA
Oxymorphone hydrochloride NDC 0115-1316
Oxymorphone hydrochloride 15 mg/1 · Tablet, Film coated, Extended release · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1316-01 | 0011513160100115131601 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-01)Marketed from Jan 2, 2013 | |
| 0115-1316-03 | 0011513160300115131603 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-03)Marketed from Jan 2, 2013 | |
| 0115-1316-08 | 0011513160800115131608 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-08)Marketed from Jan 2, 2013 | |
| 0115-1316-13 | 0011513161300115131613 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1316-13)Marketed from Jan 2, 2013 |
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 — 15 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 079087
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0115-1316_a8dc6624-df1e-4e5a-b445-9541658e3430SPL ID a8dc6624-df1e-4e5a-b445-9541658e3430SPL set ID 557e9610-62d7-42bf-90c1-44215bd8c1f8RxCUI 977874, 977894, 977902, 977909, 977915, 977923, 977929UNII 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
N400115131601followed by a unit qualifier and the quantityPackage 00115-1316-01. 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 Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an extended treatment period with a daily opioid analgesic and for which alternative treatment options are inadequate. ( 1 ) Limitations of Use: Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, and because of the greater risks of overdose and death with extended-r…
Excerpt only. Read the full label for complete information.
About NDC 0115-1316
- What is NDC 0115-1316?
- 0115-1316 is the product NDC for Oxymorphone hydrochloride, Oxymorphone hydrochloride 15 mg/1 tablet, film coated, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 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?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. 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 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 |
Other NDCs under ANDA 079087
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 7.5 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1315 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 30 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1317 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1231 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1232 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 15 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-698 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 5 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-695 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 7.5 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-696 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-697 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 20 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-699 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 30 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-700 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 40 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals LLC | 64896-701 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 20 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1233 |
| Oxymorphone hydrochloride | Oxymorphone hydrochloride 40 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1234 |