Prescription drug · ANDA
Oxycodone Hydrochloride NDC 40032-950
Oxycodone hydrochloride 5 mg/1 · Capsule · Oral · Novel Laboratories, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 40032-950-01 | 40032095001 | 100 CAPSULE in 1 BOTTLE (40032-950-01)Marketed from Aug 24, 2015 | |
| 40032-950-03 | 40032095003 | 30 CAPSULE in 1 BOTTLE (40032-950-03)Marketed from Aug 24, 2015 | |
| 40032-950-50 | 40032095050 | 500 CAPSULE in 1 BOTTLE (40032-950-50)Marketed from Aug 24, 2015 |
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
- Capsule
- Route
- Oral
- Labeler
- Novel Laboratories, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204752
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 40032-950_65077bf1-49cf-4205-91f6-d6e2e81281ceSPL ID 65077bf1-49cf-4205-91f6-d6e2e81281ceSPL set ID 69410bf3-0d3a-41f9-b10a-c4ee3770f728RxCUI 1049696UNII C1ENJ2TE6CUPC 0340032950035, 0340032950011
- 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
N440032095001followed by a unit qualifier and the quantityPackage 40032-0950-01. 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 Capsules are an opioid agonist indicated in adults 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 Capsules 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 Capsules are an opioid agonist indicate…
Excerpt only. Read the full label for complete information.
- 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.