Prescription drug · ANDA
Oxycodone and Aspirin NDC 42806-061
Oxycodone hydrochloride 4.8355 mg/1; Aspirin 325 mg/1 · Tablet · Oral · Epic Pharma, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 42806-061-01 | 42806006101 | 100 TABLET in 1 BOTTLE (42806-061-01)Marketed from Jun 30, 2020 |
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 and Aspirin
- Generic name (nonproprietary)
- oxycodone and aspirin
- Active ingredients
- Oxycodone hydrochloride — 4.8355 mg/1Aspirin — 325 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Epic Pharma, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 040910
- Marketing start
- Listing expires
- DEA schedule
- CII
- Other FDA classes
- Non-Steroidal (Chemical structure)Cyclooxygenase Inhibitors (Mechanism)Decreased Platelet Aggregation (Physiologic effect)Decreased Prostaglandin Production (Physiologic effect)Full Opioid Agonists (Mechanism)
- Identifiers
- Product ID 42806-061_8cd322df-f304-482e-9ed5-a7afa26f5645SPL ID 8cd322df-f304-482e-9ed5-a7afa26f5645SPL set ID 3292a7c6-5ba3-4563-bc62-e43040634123RxCUI 848768UNII C1ENJ2TE6C, R16CO5Y76EUPC 0342806061015
- Pharmacologic class
- Nonsteroidal Anti-inflammatory Drug; Opioid Agonist; Platelet Aggregation Inhibitor
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
N442806006101followed by a unit qualifier and the quantityPackage 42806-0061-01. 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)
INDICATIONS AND USAGE Oxycodone and aspirin 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 ), reserve oxycodone and aspirin tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics) • 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 and Aspirin tablets should not be used for an extended period of time un…
Excerpt only. Read the full label for complete information.
- openFDA data updated
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