Prescription drug · NDA
Oxaydo (Oxycodone hydrochloride) NDC 69344-213
Oxycodone hydrochloride 7.5 mg/1 · Tablet · Oral · Zyla Life Sciences US LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69344-213-11 | 69344021311 | 100 TABLET in 1 BOTTLE (69344-213-11)Marketed from Sep 1, 2015 |
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)
- Oxaydo
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 7.5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Zyla Life Sciences US LLCNDC labeler code 69344
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 202080
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 69344-213_5ab321c4-697f-4614-87bb-ec31a1429ef8SPL ID 5ab321c4-697f-4614-87bb-ec31a1429ef8SPL set ID cff0c64a-63f5-4b3c-909a-cdecf6755cbeRxCUI 1049621, 1113314, 1664448, 1664634UNII C1ENJ2TE6CUPC 0369344213119, 0369344113112
- 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
N469344021311followed by a unit qualifier and the quantityPackage 69344-0213-11. 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)
OXAYDO is indicated for the management of acute and chronic 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 OXAYDO, for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. OXAYDO is an opioid agonist indicated for the management of acute and chronic pain severe enough to require an opio…
Excerpt only. Read the full label for complete information.
About NDC 69344-213
- What is NDC 69344-213?
- 69344-213 is the product NDC for Oxaydo (oxycodone hydrochloride), Oxycodone hydrochloride 7.5 mg/1 tablet, listed with the FDA by Zyla Life Sciences US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxaydo (Oxycodone hydrochloride).
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- Zyla Life Sciences US LLC, NDC labeler code 69344. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxaydo?
- 1 other product NDC are listed under this name. See all Oxaydo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxaydo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxaydooxycodone hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Zyla Life Sciences US LLC | 69344-113 | 69344-0113-11 |
Other NDCs under NDA 202080
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 |
|---|---|---|---|---|
| Oxaydooxycodone hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Zyla Life Sciences US LLC | 69344-113 |