Prescription drug · ANDA
Oxycodone Hydrochloride (oxycodone) NDC 72162-1811
Oxycodone hydrochloride 5 mg/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-1811-0 | 72162181100 | 30 TABLET in 1 BOTTLE (72162-1811-0)Marketed from May 30, 2024 | |
| 72162-1811-1 | 72162181101 | 60 TABLET in 1 BOTTLE (72162-1811-1)Marketed from May 30, 2024 | |
| 72162-1811-2 | 72162181102 | 90 TABLET in 1 BOTTLE (72162-1811-2)Marketed from May 30, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Bryant Ranch Prepack
- 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 72162-1811_c990c114-53b0-4621-9a31-c31ba43f6527SPL ID c990c114-53b0-4621-9a31-c31ba43f6527SPL set ID bc7fdf7e-ad4e-4a04-b35c-2233cc7e5f15RxCUI 1049621UNII C1ENJ2TE6C
- 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
N472162181100followed by a unit qualifier and the quantityPackage 72162-1811-00. 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, and misuse with opioids, which can occur at any dosage or duration [see Warnings and Precautions (5.1) ] , reserve oxycodone HCl tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or opioid combination products): Have not been tolerated or are not expected to be tolerated, Have not provided adequate analgesia or are not expected to provide adequate analgesia. Oxycodone HCl tablets should not be used for an extende…
Excerpt only. Read the full label for complete information.
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 | Bryant Ranch Prepack | 71335-0981 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 5 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6966 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1023 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1080 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 5 mg/1 | TabletOral | Redpharm Drug | 67296-2233 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 5 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-047 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 15 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7180 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 20 mg/1 | TabletOral | Amneal Pharmaceuticals LLC | 65162-050 |
| Oxycodone Hydrochlorideoxycodone | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0677 |
| 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 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1812 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Precision Dose, Inc. | 68094-005 |