Hetlioz (tasimelteon) NDC 43068-220

NDC codes

FDA NDC Directory

Product NDC (as listed)43068-220Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43068-0220Add 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 NDC	11-digit (billing)	Package	Copy
43068-220-01	43068022001	30 CAPSULE in 1 BOTTLE (43068-220-01)Marketed from Apr 4, 2014

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): Hetlioz
Generic name (nonproprietary): tasimelteon
Active ingredients: Tasimelteon — 20 mg/1
Dosage form: Capsule
Route: Oral
Labeler: Vanda Pharmaceuticals Inc.
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 205677
Marketing start: Apr 4, 2014
Listing expires: Dec 31, 2027
Other FDA classes: Melatonin Receptor Agonists (Mechanism)
Identifiers: Product ID 43068-220_8463c372-11ff-4caf-ad72-54d54a4a795dSPL ID 8463c372-11ff-4caf-ad72-54d54a4a795dSPL set ID ca4a9b63-708e-49e9-8f9b-010625443b90RxCUI 1490473, 1491624, 2468312, 2468316UNII SHS4PU80D9
Pharmacologic class: Melatonin Receptor Agonist

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

N443068022001 followed by a unit qualifier and the quantity

Package 43068-0220-01. 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 Aug 4, 2026.

Indications (excerpt from the label)

HETLIOZ is a melatonin receptor agonist. HETLIOZ capsules are indicated for the treatment of: Non-24-Hour Sleep-Wake Disorder (Non-24) in adults ( 1 ) Nighttime sleep disturbances in Smith-Magenis Syndrome (SMS) in patients 16 years of age and older ( 1 ) HETLIOZ LQ oral suspension is indicated for the treatment of: Nighttime sleep disturbances in SMS in pediatric patients 3 years to 15 years of age ( 1 ) 1.1 Non-24-Hour Sleep-Wake Disorder (Non-24) HETLIOZ capsules are indicated for the treatment of Non-24 in adults. 1.2 Nighttime Sleep Disturbances in Smith-Magenis Syndrome (SMS) HETLIOZ capsules are indicated for the treatment of nighttime sleep disturbances in SMS in patients 16 years of…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)