64950-342 : Hycodan Oral Solution

NDC:	64950-342
Labeler:	Genus Lifesciences Inc.
Product Type:	Human Prescription Drug
Drug Name:	Hycodan
Dosage Form:	Oral Solution
Application #:	NDA005213
Rev. Date:	Jun 10, 2019
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

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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