Prescription drug · NDA
Xtampza ER (oxycodone) NDC 24510-120
Oxycodone 18 mg/1 · Capsule, Extended release · Oral · Collegium Pharmaceutical, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 24510-120-10 | 24510012010 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (24510-120-10)Marketed from May 10, 2016 | |
| 24510-120-20 | 24510012020 | 20 CAPSULE, EXTENDED RELEASE in 1 BLISTER PACK (24510-120-20)Marketed from May 10, 2016 |
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)
- Xtampza ERSuffix: ER
- Generic name (nonproprietary)
- oxycodone
- Active ingredients
- Oxycodone — 18 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208090
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 24510-120_fda0989d-9319-4e35-af83-fca1ec66878eSPL ID fda0989d-9319-4e35-af83-fca1ec66878eSPL set ID b0a5ded2-8ee2-49ca-a86c-2b28ae40f60cRxCUI 1790527, 1790533, 1791558, 1791560, 1791567, 1791569, 1791574, 1791576, 1791580, 1791582UNII CD35PMG570UPC 0324510140101, 0324510115109, 0324510130102
- 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
N424510012010followed by a unit qualifier and the quantityPackage 24510-0120-10. 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)
XTAMPZA ER is indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. XTAMPZA ER is an opioid agonist indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. ( 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, reserve opioid analgesics, including XTAMPZA ER, for use in patients for whom alternative…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208090
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 |
|---|---|---|---|---|
| Xtampza ERoxycodone | Oxycodone 9 mg/1 | Capsule, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-110 |
| Xtampza ERoxycodone | Oxycodone 27 mg/1 | Capsule, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-130 |
| Xtampza ERoxycodone | Oxycodone 13.5 mg/1 | Capsule, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-115 |
| Xtampza ERoxycodone | Oxycodone 36 mg/1 | Capsule, Extended releaseOral | Collegium Pharmaceutical, Inc. | 24510-140 |