Prescription drug · NDA
Daybue (Trofinetide) NDC 63090-660
Trofinetide 200 mg/mL · Solution · Oral · Acadia Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63090-660-01 | 63090066001 | 1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTICMarketed from Mar 10, 2023 |
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)
- Daybue
- Generic name (nonproprietary)
- trofinetide
- Active ingredients
- Trofinetide — 200 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Acadia Pharmaceuticals Inc.NDC labeler code 63090
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 217026
- Marketing start
- Listing expires
- Other FDA classes
- Cytochrome P450 3A4 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B1 Inhibitors (Mechanism)Organic Anion Transporting Polypeptide 1B3 Inhibitors (Mechanism)
- Identifiers
- Product ID 63090-660_acf4551a-4f21-46d6-8575-0c553c2c6d39SPL ID acf4551a-4f21-46d6-8575-0c553c2c6d39SPL set ID 67e6f2d9-21f6-466f-9def-826c6a4b8257RxCUI 2632857, 2632863, 2729447, 2729451, 2729453, 2729455, 2729457, 2729459UNII Z2ME8F52QLUPC 0363090660012
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
N463090066001followed by a unit qualifier and the quantityPackage 63090-0660-01. 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 .
Indications (excerpt from the label)
DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 63090-660
- What is NDC 63090-660?
- 63090-660 is the product NDC for Daybue (trofinetide), Trofinetide 200 mg/mL solution, listed with the FDA by Acadia Pharmaceuticals Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Daybue (Trofinetide).
- What is the active ingredient?
- Trofinetide.
- Who is the labeler?
- Acadia Pharmaceuticals Inc., NDC labeler code 63090. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Daybue?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.