Prescription drug · ANDA
Oxycodone Hydrochloride NDC 31722-917
Oxycodone hydrochloride 15 mg/1 · Tablet · Oral · Camber Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-917-01 | 31722091701 | 100 TABLET in 1 BOTTLE (31722-917-01)Marketed from Aug 8, 2017 | |
| 31722-917-05 | 31722091705 | 500 TABLET in 1 BOTTLE (31722-917-05)Marketed from Aug 8, 2017 |
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)
- Oxycodone Hydrochloride
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 15 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 207418
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 31722-917_a506a2bf-6041-4ed7-bf7c-ffe50b1b3c2eSPL ID a506a2bf-6041-4ed7-bf7c-ffe50b1b3c2eSPL set ID 01db4606-d49c-4b10-a78a-1cf41880a9fbRxCUI 1049611, 1049618, 1049621, 1049683, 1049686UNII C1ENJ2TE6CUPC 0331722917018, 0331722485050, 0331722486019, 0331722918053, 0331722484053, 0331722486057, 0331722485012, 0331722917056, 0331722484015, 0331722918015
- 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
N431722091701followed by a unit qualifier and the quantityPackage 31722-0917-01. 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)
Oxycodone hydrochloride tablets are indicated for the management of 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 and persist over the course of therapy [see Warnings and Precautions (5.1)] , reserve opioid analgesics, including oxycodone 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. Oxycodone hydrochloride is an opioid agonist indicated for the management of pain se…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 207418
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 |
|---|---|---|---|---|
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-485 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-484 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-486 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8890 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2126 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-918 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc | 72865-129 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | XLCare Pharmaceuticals, Inc | 72865-128 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-1930 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-966 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-967 |