Prescription drug · ANDA
Oxycodone Hydrochloride NDC 60687-406
Oxycodone hydrochloride 5 mg/5mL · Solution · Oral · American Health Packaging
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 60687-406-67 | 60687040667 | 5 TRAY in 1 CASE (60687-406-67) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-406-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-406-40)Marketed from Apr 22, 2019 | |
| 60687-406-77 | 60687040677 | 4 TRAY in 1 CASE (60687-406-77) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-406-46) / 5 mL in 1 CUP, UNIT-DOSE (60687-406-40)Marketed from Apr 22, 2019 |
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/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- American Health Packaging
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204037
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 60687-406_30ca5ab4-1e96-888b-e063-6294a90abae0SPL ID 30ca5ab4-1e96-888b-e063-6294a90abae0SPL set ID 0a6b0659-6816-4f44-81bd-9bac4da5380dRxCUI 1049604UNII 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
N460687040667followed by a unit qualifier and the quantityPackage 60687-0406-67. 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 Oral Solution is indicated in adults 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 (5.2) ], reserve Oxycodone Hydrochloride Oral Solution 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 Oral…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204037
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 5 mg/5mL | SolutionOral | Hikma Pharmceuticals USA Inc. | 0054-0390 |
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.