0054-4784 : Roxicet 5/500 Oral Tablet


NDC0054-4784
Labeler: Roxane Laboratories, Inc.
Product Type: Human Prescription Drug
Drug Name:  Roxicet
Dosage Form: Oral Tablet
Application #: ANDA089775
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: 54;543
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.

54 543: (0054-4650) Roxicet 5/500 Oral Tablet by Roxane Laboratories, Inc.
The above image is provided by the U.S. National Library of Medicine (NLM) and is not part of the official label.

NDC Package Codes:

  • 0054-4784-25: 100 TABLET IN 1 BOTTLE, PLASTIC (0054‑4784‑25)

Active Ingredients:

  • Acetaminophen
  • Oxycodone Hydrochloride

Dosage Strength:

  • 500 mg
  • 5 mg

Inactive Ingredients:

  • Silicon Dioxide
  • Croscarmellose Sodium
  • Cellulose, Microcrystalline
  • Stearic Acid

Pharmaceutical Classes:

  • Full Opioid Agonists [MoA]
  • Opioid Agonist [EPC]

Related Products:

Based on records with the same trade name.
  • 0054-3686 Roxicet Oral Solution by Roxane Laboratories, Inc.
  • 0054-4650 Roxicet 5/325 Oral Tablet by Roxane Laboratories, Inc.
  • 0054-8648 Roxicet Oral Solution by Roxane Laboratories, Inc.
  • 0054-8650 Roxicet 5/325 Oral Tablet by Roxane Laboratories, Inc.

NDC QR Code

Scan the QR code below to easily reference this data in the future:

NDC 0054-4784 QR Code

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