Prescription drug · ANDA
Oxycodone hydrochloride NDC 76420-763
Oxycodone hydrochloride 5 mg/1 · Tablet · Oral · Asclemed USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76420-763-01 | 76420076301 | 100 TABLET in 1 BOTTLE (76420-763-01)Marketed from Jun 25, 2024 | |
| 76420-763-05 | 76420076305 | 500 TABLET in 1 BOTTLE (76420-763-05)Marketed from Jun 25, 2024 | |
| 76420-763-10 | 76420076310 | 10 TABLET in 1 BOTTLE (76420-763-10)Marketed from Jun 25, 2024 | |
| 76420-763-20 | 76420076320 | 20 TABLET in 1 BOTTLE (76420-763-20)Marketed from Jun 25, 2024 | |
| 76420-763-30 | 76420076330 | 30 TABLET in 1 BOTTLE (76420-763-30)Marketed from Jun 25, 2024 | |
| 76420-763-60 | 76420076360 | 60 TABLET in 1 BOTTLE (76420-763-60)Marketed from Jun 25, 2024 | |
| 76420-763-90 | 76420076390 | 90 TABLET in 1 BOTTLE (76420-763-90)Marketed from Jun 25, 2024 |
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 hydrochloride
- Active ingredients
- Oxycodone hydrochloride — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Asclemed USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 202116
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 76420-763_1bb160c8-a76d-7033-e063-6294a90adbefSPL ID 1bb160c8-a76d-7033-e063-6294a90adbefSPL set ID 1bb147d4-1ab6-dd70-e063-6394a90a67a8RxCUI 1049611, 1049618, 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
N476420076301followed by a unit qualifier and the quantityPackage 76420-0763-01. 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 hydrochloride 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 hydrochloride 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 hydrochloride tablets should not be …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 202116
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 | Alvogen, Inc. | 47781-264 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 5 mg/1 | TabletOral | Alvogen, Inc. | 47781-263 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Alvogen, Inc. | 47781-265 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-764 |
| Oxycodone hydrochloride | Oxycodone hydrochloride 30 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-768 |