50458-526 : Tylox (Apap 500 mg / Oxycodone Hydrochloride 5 mg) Oral Capsule


NDC50458-526
Labeler: Ortho-mcneil-janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Tylox
Dosage Form: Oral Capsule
Application #: ANDA088790
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: TYLOX;McNEIL
Shapes:  Capsule
Colors:  Red
Size (mm): 22
Segments: * 1

* Segments = the number of equally sized pieces which the pill can be broken into. In this case, a value of 1 indicates a solid pill with no score lines.

NDC Package Codes:

  • 50458-526-60: 100 CAPSULE IN 1 BOTTLE (50458‑526‑60)
  • 50458-526-79: 100 CAPSULE IN 1 BOX, UNIT‑DOSE (50458‑526‑79)

Active Ingredients:

  • Acetaminophen
  • Oxycodone Hydrochloride

Dosage Strength:

  • 500 mg
  • 5 mg

Inactive Ingredients:

  • Starch, Corn
  • Docusate Sodium
  • Fd&c Blue No. 1
  • Fd&c Red No. 3
  • Fd&c Red No. 40
  • Gelatin
  • Magnesium Stearate
  • Sodium Benzoate
  • Sodium Metabisulfite
  • Titanium Dioxide

Pharmaceutical Classes:

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

NDC QR Code

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