NDC 0591-3551

Oxycodone and Aspirin

Oxycodone And Aspirin

Oxycodone and Aspirin is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Actavis Pharma, Inc.. The primary component is Oxycodone Hydrochloride; Aspirin.

• Product ID: 0591-3551_0c3167ea-b863-485b-b18e-e7835803c9cb
• NDC: 0591-3551
• Product Type: Human Prescription Drug
• Proprietary Name: Oxycodone and Aspirin
• Generic Name: Oxycodone And Aspirin
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2011-10-18
• Marketing End Date: 2020-06-30
• Marketing Category: ANDA / ANDA
• Application Number: ANDA090084
• Labeler Name: Actavis Pharma, Inc.
• Substance Name: OXYCODONE HYDROCHLORIDE; ASPIRIN
• Active Ingredient Strength: 5 mg/1; mg/1
• Pharm Classes: Full Opioid Agonists [MoA],Opioid Agonist [EPC],Platelet Aggregation Inhibitor [EPC],Decreased Platelet Aggregation [PE],Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
• DEA Schedule: CII
• NDC Exclude Flag: N

Packaging

NDC 0591-3551-01

100 TABLET in 1 BOTTLE, PLASTIC (0591-3551-01)

• Marketing Start Date: 2011-10-18
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0591-3551-01 [00591355101]

Oxycodone and Aspirin TABLET

• Marketing Category: ANDA
• Application Number: ANDA090084
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2011-10-18
• Marketing End Date: 2020-06-30

Drug Details

Active Ingredients

Ingredient	Strength
OXYCODONE HYDROCHLORIDE	4.8355 mg/1

OpenFDA Data

• SPL SET ID: a598f735-d2e2-43ad-be77-8627ea4a9b78
• Manufacturer:
  • Actavis Pharma, Inc.
• UNII:
  • R16CO5Y76E
  • C1ENJ2TE6C
• RxNorm Concept Unique ID - RxCUI:
  • 848768
• Pharm Class PE:
  • Decreased Prostaglandin Production [PE]
  • Decreased Platelet Aggregation [PE]
• PHarm Class EPC:
  • Nonsteroidal Anti-inflammatory Drug [EPC]
  • Platelet Aggregation Inhibitor [EPC]
• NUI Code:
  • N0000008832
  • N0000008836
  • N0000175721
  • N0000000160
  • N0000175578
  • N0000175722

Pharmacological Class

• Full Opioid Agonists [MoA]
• Opioid Agonist [EPC]
• Cyclooxygenase Inhibitors [MoA]
• Decreased Prostaglandin Production [PE]
• Nonsteroidal Anti-inflammatory Compounds [Chemical/Ingredient]
• Nonsteroidal Anti-inflammatory Drug [EPC]
• Platelet Aggregation Inhibitor [EPC]
• Decreased Platelet Aggregation [PE]

NDC Crossover Matching brand name "Oxycodone and Aspirin" or generic name "Oxycodone And Aspirin"

NDC	Brand Name	Generic Name
0591-3551	Oxycodone and Aspirin	Oxycodone and Aspirin
68308-845	Oxycodone and Aspirin	Oxycodone Hydrochloride and Aspirin