50458-515 : Tylenol #4 Oral Tablet


NDC50458-515
Labeler: Janssen Pharmaceuticals, Inc.
Product Type: Human Prescription Drug
Drug Name:  Tylenol With Codeine
Dosage Form: Oral Tablet
Application #: ANDA085055
Rev. Date: 
CSA Schedule: CIII (US) [1]


[1] Schedule III / IIIN Controlled Substance: Has a potential for abuse less than substances in Schedules I or II and abuse may lead to moderate or low physical dependence or high psychological dependence. (i.e. Products containing not more than 90 milligrams of Codeine per dosage unit [such as Tylenol with Codeine], other narcotics such as Buprenorphine (Suboxone), and Schedule IIIN non-narcotics such as Didrex, Ketamine, Phendimetrazine, and Anabolic Steroids). More Details: US Dept of Justice Controlled Substance Schedules.

Appearance:


Markings: McNEIL;TYLENOL;CODEINE;4
Shapes:  Round
Colors:  White
Size (mm): 11
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:

  • 50458-515-60: 100 TABLET IN 1 BOTTLE (50458‑515‑60)
  • 50458-515-70: 500 TABLET IN 1 BOTTLE (50458‑515‑70)

Active Ingredients:

  • Acetaminophen
  • Codeine Phosphate

Dosage Strength:

  • 300 mg
  • 60 mg

Inactive Ingredients:

  • Powdered Cellulose
  • Magnesium Stearate
  • Sodium Metabisulfite
  • Starch, Corn

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 50458-513 Tylenol #3 Oral Tablet by Janssen Pharmaceuticals, Inc.
  • 50090-0006 Tylenol With Codeine Oral Tablet by A-s Medication Solutions LLC
  • 54569-0024 Tylenol #3 Oral Tablet by A-s Medication Solutions LLC
  • 55154-1908 Tylenol #3 Oral Tablet by Cardinal Health
  • 55154-1916 Tylenol #4 Oral Tablet by Cardinal Health
  • 55289-048 Tylenol #3 Oral Tablet by Pd-rx Pharmaceuticals, Inc.

NDC 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.