64950-342 : Hycodan Oral Solution


NDC64950-342
Labeler: Genus Lifesciences Inc.
Product Type: Human Prescription Drug
Drug Name:  Hycodan
Dosage Form: Oral Solution
Application #: NDA005213
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:

  • 64950-342-45: 40 CUP, UNIT‑DOSE IN 1 CASE (64950‑342‑45) > 5 ML IN 1 CUP, UNIT‑DOSE (64950‑342‑05)
  • 64950-342-47: 473 ML IN 1 BOTTLE (64950‑342‑47)

Active Ingredients:

  • Hydrocodone Bitartrate
  • Homatropine Methylbromide

Dosage Strength:

  • 5 mg/5mL
  • 1.5 mg/5mL

Pharmaceutical Classes:

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

Related Products:

Based on records with the same trade name.
  • 64950-205 Hycodan Oral Tablet by Genus Lifesciences Inc.
  • 63481-042 Hycodan (Homatropine Methylbromide 1.5 mg / Hydrocodone Bitartrate 5 mg) Oral Tablet by Endo Pharmaceuticals Inc.

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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.