Prescription drug · ANDA
Oxymorphone Hydrochloride NDC 42806-330
Oxymorphone hydrochloride 5 mg/1 · Tablet · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-330-01 | 42806033001 | 100 TABLET in 1 BOTTLE (42806-330-01)Marketed from May 15, 2019 |
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
- Epic Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 201187
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42806-330_8a01b8b5-5114-46e2-9949-1ab6beb78d81SPL ID 8a01b8b5-5114-46e2-9949-1ab6beb78d81SPL set ID 95804e72-232d-425d-b23d-a66f43bdf0c6RxCUI 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
N442806033001followed by a unit qualifier and the quantityPackage 42806-0330-01. 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 an opioid agonist indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use Because of the risks of addiction, abuse, 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 are an opioid ago…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 201187
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 10 mg/1 | TabletOral | Epic Pharma, LLC | 42806-331 |