NDC codes

FDA NDC Directory
Product NDC (as listed)70127-100Labeler and product segments. Claims need a package NDC.
Product NDC at billing width70127-0100Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
70127-100-10701270100101 BOTTLE, GLASS in 1 CARTON (70127-100-10) / 100 mL in 1 BOTTLE, GLASS (70127-100-01)Marketed from Oct 5, 2018
70127-100-60701270100601 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
Cannabidiol100 mg/mL
Dosage form
Solution
Route
Oral
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

N470127010010 followed by a unit qualifier and the quantity

Package 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.

Full label on DailyMed (opens in a new tab)

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