69654-480 : Tuzistra XR Oral Suspension, Extended Release


NDC69654-480
Labeler: Aytu Bioscience, Inc.
Product Type: Human Prescription Drug
Drug Name:  Tuzistra XR
Dosage Form: Oral Suspension, Extended Release
Application #: NDA207768
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.

NDC Package Codes:

  • 69654-480-01: 473 ML IN 1 BOTTLE (69654‑480‑01)
  • 69654-480-02: 25 ML IN 1 BOTTLE (69654‑480‑02)

Active Ingredients:

  • Codeine Phosphate Anhydrous
  • Chlorpheniramine Maleate

Dosage Strength:

  • 14.7 mg/5mL
  • 2.8 mg/5mL

Pharmaceutical Classes:

  • Histamine H1 Receptor Antagonists [MoA]
  • Histamine-1 Receptor Antagonist [EPC]

Related Products:

Based on records with the same trade name.
  • 69442-480 Tuzistra XR Oral Suspension, Extended Release by Vernalis Therapeutics, Inc.

NDC QR Code

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