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 ID70127-100_0243a6f2-018a-4049-a0db-bf2543e40b4f
NDC70127-100
Product TypeHuman Prescription Drug
Proprietary NameEpidiolex
Generic NameCannabidiol
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2018-10-05
Marketing CategoryNDA / NDA
Application NumberNDA210365
Labeler NameGreenwich Biosciences, Inc.
Substance NameCANNABIDIOL
Active Ingredient Strength100 mg/mL
NDC Exclude FlagN
Listing Certified Through2021-12-31

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 Date2018-10-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70127-100-10 [70127010010]

Epidiolex SOLUTION
Marketing CategoryNDA
Application NumberNDA210365
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-05

NDC 70127-100-01 [70127010001]

Epidiolex SOLUTION
Marketing CategoryNDA
Application NumberNDA210365
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2018-10-05

Drug Details

Active Ingredients

IngredientStrength
CANNABIDIOL100 mg/mL

OpenFDA Data

SPL SET ID:8bf27097-4870-43fb-94f0-f3d0871d1eec
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2058900
  • 2058906
  • NDC Crossover Matching brand name "Epidiolex" or generic name "Cannabidiol"

    NDCBrand NameGeneric Name
    70127-100Epidiolexcannabidiol
    82876-0011000mg CBD daily supportCannabidiol
    82876-2832000mg CBD daily supportCannabidiol
    73674-005leafPro CBDmed Oil FS QP 20%Cannabidiol
    73674-001leafPro CBDmed Oil FS QP 3%Cannabidiol
    73674-002leafPro CBDmed Oil FS QP 5%Cannabidiol
    73674-024leafPro CBDmed Oil T-FS QD 20%Cannabidiol
    73674-020leafPro CBDmed Oil T-FS QD 3%Cannabidiol
    73674-021leafPro CBDmed Oil T-FS QD 5%Cannabidiol
    73674-052leafPro CBDmed Softgels FS QP 20Cannabidiol
    73674-061leafPro CBDmed Softgels T-FS QD 20Cannabidiol

    Trademark Results [Epidiolex]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    EPIDIOLEX
    EPIDIOLEX
    86007888 4484943 Live/Registered
    GW Pharma Limited
    2013-07-11
    EPIDIOLEX
    EPIDIOLEX
    79350826 not registered Live/Pending
    GW Research Limited
    2022-08-11
    EPIDIOLEX
    EPIDIOLEX
    79330764 not registered Live/Pending
    GW Research Ltd
    2021-06-23
    EPIDIOLEX
    EPIDIOLEX
    79156538 4838876 Live/Registered
    GW Research Limited
    2014-08-14

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