Prescription drug · ANDA
Oxycodone Hydrochloride NDC 68071-2899
Oxycodone hydrochloride 5 mg/1 · Tablet · Oral · NuCare Pharmaceuticals,Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68071-2899-4 | 68071289904 | 4 TABLET in 1 BOTTLE, PLASTIC (68071-2899-4)Marketed from Dec 8, 2022 | |
| 68071-2899-6 | 68071289906 | 6 TABLET in 1 BOTTLE, PLASTIC (68071-2899-6)Marketed from Dec 8, 2022 |
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 hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- NuCare Pharmaceuticals,Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091490
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 68071-2899_217adc8e-b886-1fdb-e063-6294a90a26faSPL ID 217adc8e-b886-1fdb-e063-6294a90a26faSPL set ID ef58f422-682e-6896-e053-2a95a90a1f2dRxCUI 1049621UNII C1ENJ2TE6CUPC 0368071289961
- 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
N468071289904followed by a unit qualifier and the quantityPackage 68071-2899-04. 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 Tablets, USP are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Oxycodone hydrochloride tablets are an opioid agonist indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ( 1 ) Limitations of Use ( 1 ) Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone hydrochloride tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or non-opioid combination products): Have not been tolerated, or are not expected …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 091490
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 15 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1413 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1414 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1421 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-1422 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-8526 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-757 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-758 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-761 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-762 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-001 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-005 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-002 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-003 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 20 mg/1 | TabletOral | Rhodes Pharmaceuticals LLC | 42858-004 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-897 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1337 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1334 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1335 |
| Oxycodone Hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1336 |