Prescription drug · NDA
RoxyBond (Oxycodone hydrochloride) NDC 81140-103
Oxycodone hydrochloride 30 mg/1 · Tablet, Coated · Oral · Protega Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 81140-103-10 | 81140010310 | 100 TABLET, COATED in 1 BOTTLE (81140-103-10)Marketed from Dec 19, 2023 |
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)
- RoxyBond
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 30 mg/1
- Dosage form
- Tablet, Coated
- Route
- Oral
- Labeler
- Protega Pharmaceuticals IncNDC labeler code 81140
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209777
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 81140-103_484b1240-1832-049e-e063-6394a90aaa6aSPL ID 484b1240-1832-049e-e063-6394a90aaa6aSPL set ID 72398542-8e0a-47b2-afeb-9ca5a1f15083RxCUI 1944529, 1944535, 1944538, 1944540, 1944541, 1944543, 2693194, 2693196UNII C1ENJ2TE6CUPC 0381140104101, 0381140102107, 0381140101100, 0381140103104
- 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
N481140010310followed by a unit qualifier and the quantityPackage 81140-0103-10. 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)
ROXYBOND is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ROXYBOND is an opioid agonist indicated for the management of 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, reserve opioid analgesics, including ROXYBOND, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pai…
Excerpt only. Read the full label for complete information.
About NDC 81140-103
- What is NDC 81140-103?
- 81140-103 is the product NDC for RoxyBond (oxycodone hydrochloride), Oxycodone hydrochloride 30 mg/1 tablet, coated, listed with the FDA by Protega Pharmaceuticals Inc. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- RoxyBond (Oxycodone hydrochloride).
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- Protega Pharmaceuticals Inc, NDC labeler code 81140. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for RoxyBond?
- 3 other product NDCs are listed under this name. See all RoxyBond NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other RoxyBond products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| RoxyBondoxycodone hydrochloride | Oxycodone hydrochloride 5 mg/1 | Tablet, CoatedOral | Protega Pharmaceuticals Inc | 81140-101 | 81140-0101-10 |
| RoxyBondoxycodone hydrochloride | Oxycodone hydrochloride 15 mg/1 | Tablet, CoatedOral | Protega Pharmaceuticals Inc | 81140-102 | 81140-0102-10 |
| RoxyBondoxycodone hydrochloride | Oxycodone hydrochloride 10 mg/1 | Tablet, CoatedOral | Protega Pharmaceuticals Inc | 81140-104 | 81140-0104-10 |
Other NDCs under NDA 209777
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 |
|---|---|---|---|---|
| RoxyBondoxycodone hydrochloride | Oxycodone hydrochloride 5 mg/1 | Tablet, CoatedOral | Protega Pharmaceuticals Inc | 81140-101 |
| RoxyBondoxycodone hydrochloride | Oxycodone hydrochloride 15 mg/1 | Tablet, CoatedOral | Protega Pharmaceuticals Inc | 81140-102 |
| RoxyBondoxycodone hydrochloride | Oxycodone hydrochloride 10 mg/1 | Tablet, CoatedOral | Protega Pharmaceuticals Inc | 81140-104 |