Prescription drug · ANDA
Oxymorphone hydrochloride NDC 0115-1315
Oxymorphone hydrochloride 7.5 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 |
|---|---|---|---|
| 0115-1315-01 | 00115131501 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-01)Marketed from Jan 2, 2013 | |
| 0115-1315-03 | 00115131503 | 1000 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-03)Marketed from Jan 2, 2013 | |
| 0115-1315-08 | 00115131508 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-08)Marketed from Jan 2, 2013 | |
| 0115-1315-13 | 00115131513 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (0115-1315-13)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 — 7.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- 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 0115-1315_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
N400115131501followed by a unit qualifier and the quantityPackage 00115-1315-01. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.