Prescription drug · NDA
OxyContin (Oxycodone hydrochloride) NDC 59011-415
Oxycodone hydrochloride 15 mg/1 · Tablet, Film coated, Extended release · Oral · Knoa Pharma LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59011-415-10 | 59011041510 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (59011-415-10)Marketed from Aug 8, 2010 | |
| 59011-415-20 | 59011041520 | 2 BLISTER PACK in 1 CARTON (59011-415-20) / 10 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Aug 8, 2010 |
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)
- OxyContin
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 15 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Knoa Pharma LLCNDC labeler code 59011
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022272
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 59011-415_47b30347-ae1d-4b54-8ccd-594eb7bdbd75SPL ID 47b30347-ae1d-4b54-8ccd-594eb7bdbd75SPL set ID bfdfe235-d717-4855-a3c8-a13d26dadedeRxCUI 1049504, 1049545, 1049565, 1049576, 1049586, 1049595, 1049601, 1860127, 1860129, 1860137, 1860148, 1860151, 1860154, 1860157UNII C1ENJ2TE6CUPC 0359011410101, 0359011420100, 0359011480104, 0359011440108, 0359011415106, 0359011460106, 0359011430109
- 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
N459011041510followed by a unit qualifier and the quantityPackage 59011-0415-10. 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)
OXYCONTIN 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, in: Adults; and Opioid-tolerant pediatric patients 11 years of age and older who are already receiving and tolerate a minimum daily opioid dose of at least 20 mg oxycodone orally or its equivalent. 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 OXYCONTIN, for use in patients for whom alterna…
Excerpt only. Read the full label for complete information.
About NDC 59011-415
- What is NDC 59011-415?
- 59011-415 is the product NDC for OxyContin (oxycodone hydrochloride), Oxycodone hydrochloride 15 mg/1 tablet, film coated, extended release, listed with the FDA by Knoa Pharma LLC. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- OxyContin (Oxycodone hydrochloride).
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- Knoa Pharma LLC, NDC labeler code 59011. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for OxyContin?
- 6 other product NDCs are listed under this name. See all OxyContin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other OxyContin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-410 | 59011-0410-1059011-0410-20 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 20 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-420 | 59011-0420-1059011-0420-20 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-430 | 59011-0430-1059011-0430-20 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 40 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-440 | 59011-0440-1059011-0440-20 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 60 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-460 | 59011-0460-1059011-0460-20 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 80 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-480 | 59011-0480-1059011-0480-20 |
Other NDCs under NDA 022272
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 40 mg/1 | Tablet, Film coated, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1560 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-430 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-410 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 20 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-420 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 40 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-440 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 60 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-460 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 80 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-480 |