epidiolex

Generic: cannabidiol

Labeler: jazz pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name epidiolex
Generic Name cannabidiol
Labeler jazz pharmaceuticals, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

cannabidiol 100 mg/mL

Manufacturer
Jazz Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 70127-100
Product ID 70127-100_4552ca49-8f8c-418f-9029-03f6eda8a7b5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210365
Listing Expiration 2026-12-31
Marketing Start 2018-10-05

Pharmacologic Class

Mechanism of Action
cytochrome p450 2c8 inhibitors [moa] cytochrome p450 2c9 inhibitors [moa] cytochrome p450 2c19 inhibitors [moa] ugt1a9 inhibitors [moa] ugt2b7 inhibitors [moa] cytochrome p450 1a2 inhibitors [moa] cytochrome p450 2b6 inhibitors [moa] cytochrome p450 2b6 inducers [moa]
Chemical Structure
cannabinoids [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 70127100
Hyphenated Format 70127-100

Supplemental Identifiers

RxCUI
2058900 2058906
UPC
0370127100014
UNII
19GBJ60SN5
NUI
M0003267 N0000187062 N0000185504 N0000182140 N0000191278 N0000191273 N0000182138 N0000182139 N0000187064

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name epidiolex (source: ndc)
Generic Name cannabidiol (source: ndc)
Application Number NDA210365 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01)
  • 1 BOTTLE, GLASS in 1 CARTON (70127-100-60) / 60 mL in 1 BOTTLE, GLASS (70127-100-06)
source: ndc

Packages (2)

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)

Ingredients (1)

cannabidiol (100 mg/mL)

Linked Drug Pages (1)

Epidiolex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4552ca49-8f8c-418f-9029-03f6eda8a7b5", "openfda": {"nui": ["M0003267", "N0000187062", "N0000185504", "N0000182140", "N0000191278", "N0000191273", "N0000182138", "N0000182139", "N0000187064"], "upc": ["0370127100014"], "unii": ["19GBJ60SN5"], "rxcui": ["2058900", "2058906"], "spl_set_id": ["8bf27097-4870-43fb-94f0-f3d0871d1eec"], "pharm_class_cs": ["Cannabinoids [CS]"], "pharm_class_moa": ["Cytochrome P450 2C8 Inhibitors [MoA]", "Cytochrome P450 2C9 Inhibitors [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]", "UGT1A9 Inhibitors [MoA]", "UGT2B7 Inhibitors [MoA]", "Cytochrome P450 1A2 Inhibitors [MoA]", "Cytochrome P450 2B6 Inhibitors [MoA]", "Cytochrome P450 2B6 Inducers [MoA]"], "manufacturer_name": ["Jazz Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (70127-100-10)  / 100 mL in 1 BOTTLE, GLASS (70127-100-01)", "package_ndc": "70127-100-10", "marketing_start_date": "20181005"}, {"sample": false, "description": "1 BOTTLE, GLASS in 1 CARTON (70127-100-60)  / 60 mL in 1 BOTTLE, GLASS (70127-100-06)", "package_ndc": "70127-100-60", "marketing_start_date": "20211006"}], "brand_name": "Epidiolex", "product_id": "70127-100_4552ca49-8f8c-418f-9029-03f6eda8a7b5", "dosage_form": "SOLUTION", "pharm_class": ["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]"], "product_ndc": "70127-100", "generic_name": "cannabidiol", "labeler_name": "Jazz Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Epidiolex", "active_ingredients": [{"name": "CANNABIDIOL", "strength": "100 mg/mL"}], "application_number": "NDA210365", "marketing_category": "NDA", "marketing_start_date": "20181005", "listing_expiration_date": "20261231"}