Prescription drug · NDA
Roxicodone (Oxycodone hydrochloride) NDC 23635-581
Oxycodone hydrochloride 15 mg/1 · Tablet · Oral · SpecGx LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 23635-581-10 | 2363505811023635058110 | 100 TABLET in 1 BOTTLE, PLASTIC (23635-581-10)Marketed from Aug 31, 2000 |
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)
- Roxicodone
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 15 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- SpecGx LLCNDC labeler code 23635
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021011
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 23635-581_9c646c9c-3074-4250-8191-82ac61b515a4SPL ID 9c646c9c-3074-4250-8191-82ac61b515a4SPL set ID 5a8157d3-ba20-4abf-b0d4-6ad141b31d63RxCUI 1049611, 1049613, 1049618, 1049620UNII C1ENJ2TE6C
- 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
N423635058110followed by a unit qualifier and the quantityPackage 23635-0581-10. 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)
ROXICODONE is 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 ROXICODONE for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. ROXICODONE is an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for whi…
Excerpt only. Read the full label for complete information.
About NDC 23635-581
- What is NDC 23635-581?
- 23635-581 is the product NDC for Roxicodone (oxycodone hydrochloride), Oxycodone hydrochloride 15 mg/1 tablet, listed with the FDA by SpecGx LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Roxicodone (Oxycodone hydrochloride).
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- SpecGx LLC, NDC labeler code 23635. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Roxicodone?
- 1 other product NDC are listed under this name. See all Roxicodone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Roxicodone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Roxicodoneoxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | SpecGx LLC | 23635-582 | 23635-0582-10 |
Other NDCs under NDA 021011
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 |
|---|---|---|---|---|
| Roxicodoneoxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | SpecGx LLC | 23635-582 |