Prescription drug · NDA
Hetlioz LQ (tasimelteon) NDC 43068-304
Tasimelteon 4 mg/mL · Suspension · Oral · Vanda Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43068-304-02 | 43068030402 | 1 BOTTLE in 1 CARTON (43068-304-02) / 48 mL in 1 BOTTLEMarketed from Dec 10, 2020 | |
| 43068-304-06 | 43068030406 | 1 BOTTLE in 1 CARTON (43068-304-06) / 158 mL in 1 BOTTLEMarketed from Dec 10, 2020 |
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 LQSuffix: LQ
- Generic name (nonproprietary)
- tasimelteon
- Active ingredients
- Tasimelteon — 4 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- Vanda Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214517
- Marketing start
- Listing expires
- Other FDA classes
- Melatonin Receptor Agonists (Mechanism)
- Identifiers
- Product ID 43068-304_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
N443068030402followed by a unit qualifier and the quantityPackage 43068-0304-02. 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)
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.