Prescription drug · ANDA
Oxymorphone Hydrochloride NDC 31722-930
Oxymorphone hydrochloride 10 mg/1 · Tablet · Oral · Camber Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-930-01 | 31722093001 | 100 TABLET in 1 BOTTLE (31722-930-01)Marketed from Mar 1, 2018 |
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
- Camber Pharmaceuticals, Inc
- 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 31722-930_53da63d9-6ef9-4feb-b704-5b7ef1785f6cSPL ID 53da63d9-6ef9-4feb-b704-5b7ef1785f6cSPL set ID 06af7dff-c261-4c03-9cd9-0605c42507faRxCUI 977939, 977942UNII 5Y2EI94NBCUPC 0331722930017, 0331722929011
- 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
N431722093001followed by a unit qualifier and the quantityPackage 31722-0930-01. 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, misuse, overdose, and death, which can occur at any dosage or duration [see Warnings and Precautions (5.1)] , and persist over the course of therapy, 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 agonist indicated for th…
Excerpt only. Read the full label for complete information.
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 5 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-130 |
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 10 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc. | 72865-131 |
| Oxymorphone Hydrochloride | Oxymorphone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1926 |