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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