Prescription drug · NDA
Epidiolex (cannabidiol) NDC 70127-100
Cannabidiol 100 mg/mL · Solution · Oral · Jazz Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70127-100-10 | 70127010010 | 1 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01)Marketed from Oct 5, 2018 | |
| 70127-100-60 | 70127010060 | 1 BOTTLE, GLASS in 1 CARTON (70127-100-60) / 60 mL in 1 BOTTLE, GLASS (70127-100-06)Marketed from Oct 6, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Epidiolex
- Generic name (nonproprietary)
- cannabidiol
- Active ingredients
- Cannabidiol — 100 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Jazz Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210365
- Marketing start
- Listing expires
- Other FDA classes
- Cannabinoids (Chemical structure)Cytochrome P450 1A2 Inhibitors (Mechanism)Cytochrome P450 2B6 Inducers (Mechanism)Cytochrome P450 2B6 Inhibitors (Mechanism)Cytochrome P450 2C19 Inhibitors (Mechanism)Cytochrome P450 2C8 Inhibitors (Mechanism)Cytochrome P450 2C9 Inhibitors (Mechanism)UGT1A9 Inhibitors (Mechanism)UGT2B7 Inhibitors (Mechanism)
- Identifiers
- Product ID 70127-100_1eb7ac65-8df5-4a4a-9156-802cfaa92b06SPL ID 1eb7ac65-8df5-4a4a-9156-802cfaa92b06SPL set ID 8bf27097-4870-43fb-94f0-f3d0871d1eecRxCUI 2058900, 2058906UNII 19GBJ60SN5UPC 0370127100014
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470127010010followed by a unit qualifier and the quantityPackage 70127-0100-10. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome (DS), or tuberous sclerosis complex (TSC) in patients 1 year of age and older. EPIDIOLEX is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome, Dravet syndrome, or tuberous sclerosis complex in patients 1 year of age and older ( 1 )
Excerpt only. Read the full label for complete information.
- openFDA data updated
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Reference information only. Verify codes and billing rules against the applicable payer and official source before submitting a claim. How Med-Code handles data.