NDC 70127-100

Epidiolex

Cannabidiol

Epidiolex is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Greenwich Biosciences, Inc.. The primary component is Cannabidiol.

• Product ID: 70127-100_0243a6f2-018a-4049-a0db-bf2543e40b4f
• NDC: 70127-100
• Product Type: Human Prescription Drug
• Proprietary Name: Epidiolex
• Generic Name: Cannabidiol
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-05
• Marketing Category: NDA / NDA
• Application Number: NDA210365
• Labeler Name: Greenwich Biosciences, Inc.
• Substance Name: CANNABIDIOL
• Active Ingredient Strength: 100 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70127-100-10

1 BOTTLE, GLASS in 1 CARTON (70127-100-10) > 100 mL in 1 BOTTLE, GLASS (70127-100-01)

• Marketing Start Date: 2018-10-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70127-100-10 [70127010010]

Epidiolex SOLUTION

• Marketing Category: NDA
• Application Number: NDA210365
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-05

NDC 70127-100-01 [70127010001]

Epidiolex SOLUTION

• Marketing Category: NDA
• Application Number: NDA210365
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-05

Drug Details

Active Ingredients

Ingredient	Strength
CANNABIDIOL	100 mg/mL

OpenFDA Data

• SPL SET ID: 8bf27097-4870-43fb-94f0-f3d0871d1eec
• Manufacturer:
  • Greenwich Biosciences, Inc.
• UNII:
  • 19GBJ60SN5
• RxNorm Concept Unique ID - RxCUI:
  • 2058900
  • 2058906

NDC Crossover Matching brand name "Epidiolex" or generic name "Cannabidiol"

NDC	Brand Name	Generic Name
70127-100	Epidiolex	cannabidiol
82876-001	1000mg CBD daily support	Cannabidiol
82876-283	2000mg CBD daily support	Cannabidiol
73674-005	leafPro CBDmed Oil FS QP 20%	Cannabidiol
73674-001	leafPro CBDmed Oil FS QP 3%	Cannabidiol
73674-002	leafPro CBDmed Oil FS QP 5%	Cannabidiol
73674-024	leafPro CBDmed Oil T-FS QD 20%	Cannabidiol
73674-020	leafPro CBDmed Oil T-FS QD 3%	Cannabidiol
73674-021	leafPro CBDmed Oil T-FS QD 5%	Cannabidiol
73674-052	leafPro CBDmed Softgels FS QP 20	Cannabidiol
73674-061	leafPro CBDmed Softgels T-FS QD 20	Cannabidiol