FDA.reportPublic FDA data

Epidiolex

Product NDC
70127-100
11-digit product format
701270100
Labeler code
70127
Product ID
70127-100_4552ca49-8f8c-418f-9029-03f6eda8a7b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
cannabidiol
Dosage form
SOLUTION
Route
ORAL
Labeler
Jazz Pharmaceuticals, Inc.
Application
NDA210365
Marketing category
NDA
Marketing start
2018-10-05
Substance
CANNABIDIOL
Active strength
100 mg/mL
Pharmacologic 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]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Epidiolex
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CANNABIDIOL100 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii19GBJ60SN5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4d7a96d5-8256-4268-9a6c-25ea66d321feProduct name120180814

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70127-100-01Epidiolex100 mL in 1 BOTTLE, GLASSSOLUTION10034
70127-100-06Epidiolex60 mL in 1 BOTTLE, GLASSSOLUTION6034
70127-100-10Epidiolex1 in 1 CARTONSOLUTION134
70127-100-60Epidiolex1 in 1 CARTONSOLUTION134

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70127-100-01ML - Milliliter70127-1000eef3365-ea11-4bd5-9635-c98e8b05a98d12018-11-06
70127-100-06ML - Milliliter70127-100c40d7df0-d6a4-4d13-9d26-370b0ca3315b12021-10-08
70127-100-10ML - Milliliter70127-10028a2b74c-3943-45f8-8fa3-dbd3a244857612018-11-06
70127-100-60ML - Milliliter70127-100ae63fb08-df61-4e7d-be8b-1608019c88b412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70127-100EPIDIOLEX (CANNABIDIOL) SOLUTION [JAZZ PHARMACEUTICALS, INC.]31Current NDC, Legacy NDC, 4 package rows20250409_8bf27097-4870-43fb-94f0-f3d0871d1eec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2058900cannabidiol 100 MG/mL Oral SolutionPSN8bf27097-4870-43fb-94f0-f3d0871d1eec34
2058906Epidiolex 100 MG/mL Oral SolutionPSN8bf27097-4870-43fb-94f0-f3d0871d1eec34
2058906cannabidiol 100 MG/ML Oral Solution [Epidiolex]SBD8bf27097-4870-43fb-94f0-f3d0871d1eec34
2058900cannabidiol 100 MG/ML Oral SolutionSCD8bf27097-4870-43fb-94f0-f3d0871d1eec34
2058906Epidiolex 100 MG/ML Oral SolutionSY8bf27097-4870-43fb-94f0-f3d0871d1eec34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70127-100-0170127010001100 mL in 1 BOTTLE, GLASS100 mlHistorical
70127-100-067012701000660 mL in 1 BOTTLE, GLASS60 mlHistorical
70127-100-10701270100101 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01) 2018-10-050000-00-00NoNoCurrent
70127-100-60701270100601 BOTTLE, GLASS in 1 CARTON (70127-100-60) / 60 mL in 1 BOTTLE, GLASS (70127-100-06) 2021-10-060000-00-00NoNoCurrent