Prescription drug · ANDA
Oxycodone Hydrochloride NDC 10702-183
Oxycodone hydrochloride 5 mg/5mL · Solution · Oral · KVK-Tech, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10702-183-50 | 10702018350 | 1 BOTTLE, PLASTIC in 1 CARTON (10702-183-50) / 500 mL in 1 BOTTLE, PLASTICMarketed from Jul 21, 2017 |
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
- KVK-Tech, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208593
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 10702-183_57c47d8d-7920-cd93-e063-6294a90a737aSPL ID 57c47d8d-7920-cd93-e063-6294a90a737aSPL set ID 744f5d1c-7427-492c-8994-c8e817793e53RxCUI 1049604, 1049615UNII 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
N410702018350followed by a unit qualifier and the quantityPackage 10702-0183-50. 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. Oxycodone Hydrochloride Oral Solution 100 mg per 5 mL (20 mg/mL) is indicated for use in opioid-tolerant adult patients who require higher doses of opioids for the management of pain severe enough to require an opioid analgesic and for which alternate 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 (5.2)] , reserve opioid analges…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 208593
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 100 mg/5mL | SolutionOral | KVK-Tech, Inc. | 10702-171 |