Prescription drug · NDA AUTHORIZED GENERIC
Oxycodone Hydrochloride NDC 0115-1560
Oxycodone hydrochloride 40 mg/1 · Tablet, Film coated, Extended release · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1560-01 | 0011515600100115156001 | 100 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0115-1560-01)Marketed from Feb 22, 2016 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Oxycodone Hydrochloride
- Generic name (nonproprietary)
- oxycodone hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 40 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 022272
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 0115-1560_335215a2-fcba-4158-bccb-79e026e05467SPL ID 335215a2-fcba-4158-bccb-79e026e05467SPL set ID c2c57ae7-86b9-47bb-a31b-ed1c4327ce7fRxCUI 1860127, 1860129, 1860137, 1860148, 1860151, 1860154, 1860157UNII C1ENJ2TE6CUPC 0301151561014
- 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
N400115156001followed by a unit qualifier and the quantityPackage 00115-1560-01. 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)
Oxycodone HCl extended-release tablets are indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate 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, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations [see Warnings and Precautions (5.1) ] , reserve oxycodone HCl extended-relea…
Excerpt only. Read the full label for complete information.
About NDC 0115-1560
- What is NDC 0115-1560?
- 0115-1560 is the product NDC for Oxycodone Hydrochloride, Oxycodone hydrochloride 40 mg/1 tablet, film coated, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone Hydrochloride.
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Oxycodone Hydrochloride?
- 130 other product NDCs are listed under this name. See all Oxycodone Hydrochloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Oxycodone Hydrochloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-967 | 60760-0967-3060760-0967-60 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-966 | 60760-0966-3060760-0966-60 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-484 | 31722-0484-0131722-0484-05 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-485 | 31722-0485-0131722-0485-05 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Camber Pharmaceuticals Inc | 31722-486 | 31722-0486-0131722-0486-05 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-954 | 60760-0954-3060760-0954-60 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-956 | 60760-0956-3060760-0956-6060760-0956-90 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-259 | 64380-0259-0164380-0259-02 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-260 | 64380-0260-01 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Strides Pharma Science Limited | 64380-261 | 64380-0261-0164380-0261-02 |
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 |
|---|---|---|---|---|
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 10 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-410 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 15 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-415 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 20 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-420 |
| OxyContinoxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | Tablet, Film coated, Extended releaseOral | Knoa Pharma LLC | 59011-430 |
| 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 |