Prescription drug · ANDA
Oxycodone Hydrochloride (Oxycodone) NDC 65162-047
Oxycodone hydrochloride 5 mg/1 · Tablet · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65162-047-03 | 6516200470365162004703 | 30 TABLET in 1 BOTTLE (65162-047-03)Marketed from Oct 30, 2012 | |
| 65162-047-10 | 6516200471065162004710 | 100 TABLET in 1 BOTTLE (65162-047-10)Marketed from Oct 30, 2012 | |
| 65162-047-25 | 6516200472565162004725 | 250 TABLET in 1 BOTTLE (65162-047-25)Marketed from Oct 30, 2012 | |
| 65162-047-50 | 6516200475065162004750 | 500 TABLET in 1 BOTTLE (65162-047-50)Marketed from Oct 30, 2012 |
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)
- Oxycodone Hydrochloride
- Generic name (nonproprietary)
- oxycodone
- Active ingredients
- Oxycodone hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 65162
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203638
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 65162-047_4fb6c994-cbd3-4d0d-bdae-505cb8082e61SPL ID 4fb6c994-cbd3-4d0d-bdae-505cb8082e61SPL set ID 094b64b3-cd32-4de5-afb6-ea00d9caad74RxCUI 1049611, 1049618, 1049621, 1049683, 1049686UNII C1ENJ2TE6CUPC 0365162049107, 0365162048100, 0365162047103, 0365162051032, 0365162050035, 0365162048032, 0365162049039, 0365162050103, 0365162051100, 0365162047035
- 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
N465162004703followed by a unit qualifier and the quantityPackage 65162-0047-03. 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 hydrochloride (HCl) tablets are 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 oxycodone HCl tablets for use in patients for whom alternative treatment options are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain. Oxycodone HCl tablets are an opioid agonist indicated for the management of pain severe…
Excerpt only. Read the full label for complete information.
About NDC 65162-047
- What is NDC 65162-047?
- 65162-047 is the product NDC for Oxycodone Hydrochloride (oxycodone), Oxycodone hydrochloride 5 mg/1 tablet, listed with the FDA by Amneal Pharmaceuticals LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Oxycodone Hydrochloride (Oxycodone).
- What is the active ingredient?
- Oxycodone hydrochloride.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 65162. 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 ANDA 203638
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 Hydrochlorideoxycodone | Oxycodone hydrochloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6966 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0981 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1023 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1811 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1812 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 15 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7180 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 5 mg/1 | TabletOral | Redpharm Drug | 67296-2233 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-050 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 10 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-048 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 15 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-049 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 30 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-051 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1080 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Precision Dose, Inc. | 68094-005 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0677 |