70127-100 : Epidiolex 100 mg/ml Oral Solution

NDC:	70127-100
Labeler:	Greenwich Biosciences, Inc.
Product Type:	Human Prescription Drug
Drug Name:	Epidiolex
Dosage Form:	Oral Solution
Application #:	NDA210365
Rev. Date:	Oct 5, 2018
CSA Schedule:	CV (US) [1]

^[1] Schedule V Controlled Substance: Low potential for abuse relative to substances listed in Schedule IV and consist primarily of preparations containing limited quantities of certain narcotics. (i.e. Cough preparations containing not more than 200 milligrams of Codeine per 100 milliliters or per 100 grams [such as Robitussin AC, Phenergan with Codeine], and Ezogabine). More Details: US Dept of Justice Controlled Substance Schedules.

NDC Package Codes:

• 70127-100-10: 1 BOTTLE, GLASS IN 1 CARTON (70127‑100‑10) > 100 ML IN 1 BOTTLE, GLASS (70127‑100‑01)
• 70127-100-60: 1 BOTTLE, GLASS IN 1 CARTON (70127‑100‑60) > 60 ML IN 1 BOTTLE, GLASS (70127‑100‑06)

Active Ingredients:

• Cannabidiol

Pharmaceutical Classes:

• Cannabinoids [CS]
• Cytochrome P450 1A2 Inhibitors [MoA]
• Cytochrome P450 2B6 Inducers [MoA]
• Cytochrome P450 2B6 Inhibitors [MoA]
• Cytochrome P450 2C19 Inhibitors [MoA]
• Cytochrome P450 2C8 Inhibitors [MoA]
• Cytochrome P450 2C9 Inhibitors [MoA]
• UGT1A9 Inhibitors [MoA]
• UGT2B7 Inhibitors [MoA]

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