0378-6117 : Asa 325 mg / Oxycodone Hydrochloride 4.84 mg Oral Tablet


NDC0378-6117
Labeler: Mylan Pharmaceuticals Inc.
Product Type: Human Prescription Drug
Drug Name: Oxycodone Hydrochloride and Aspirin
Dosage Form: Oral Tablet
Application #: ANDA091670
Rev. Date: 
CSA Schedule: CII (US) [1]


[1] Schedule II / IIN Controlled Substance: High potential for abuse which may lead to severe psychological or physical dependence. (i.e. Narcotics such as Dilaudid, Methadone, Demerol, Oxycodone, Percocet, Fentanyl, Morphine, Opium, Codeine, and Hydrocodone ... Schedule IIN stimulants include non-narcotic Amphetamines such as Dexedrine, Adderall, Desoxyn, Methylphenidate (Ritalin) ... Other Schedule II substances include Amobarbital, Glutethimide, and Pentobarbital. More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: 117
Shapes:  Round
Colors:  White
Size (mm): 11
Segments: * 2

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 2 indicates a scored pill which can be broken into 2 equal pieces.

NDC Package Codes:

  • 0378-6117-01: 100 TABLET IN 1 BOTTLE, PLASTIC (0378‑6117‑01)

Active Ingredients:

  • Aspirin
  • Oxycodone Hydrochloride

Dosage Strength:

  • 325 mg
  • 4.8355 mg

Inactive Ingredients:

  • Cellulose, Microcrystalline
  • Silicon Dioxide
  • Stearic Acid
  • Starch, Corn

Pharmaceutical Classes:

  • 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]

NDC QR Code

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NDC 0378-6117 QR Code

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Note: The RxChat NDC Database uses publicly available data from the FDA and the U.S. National Library of Medicine (NLM); The NLM is not responsible for the data presented and does not endorse or recommend this or any other product. While we make every effort to ensure that the information presented is accurate, you should assume that all results are unvalidated. To report any errors or inconsistencies please contact us.