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NDC 63090-0660-01 Daybue 200 mg/mL Details
Daybue 200 mg/mL
Daybue is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Acadia Pharmaceuticals Inc.. The primary component is TROFINETIDE.
MedlinePlus Drug Summary
Trofinetide is used to treat Rett syndrome (an inherited condition that causes severe developmental and nervous system problems) in adult and children 2 years of age or older. Trofinetide is an analog of glycine-proline-glutamate (GPE), a protein that occurs naturally in the brain. It is not known exactly how trofinetide works, but it may improve nerve function and structure.
Related Packages: 63090-0660-01Last Updated: 04/28/2024
MedLinePlus Full Drug Details: Trofinetide
Product Information
| NDC | 63090-0660 |
|---|---|
| Product ID | 63090-660_0b4ea8eb-a476-488c-ad2a-14d25926e467 |
| Associated GPIs | |
| GCN Sequence Number | 084510 |
| GCN Sequence Number Description | trofinetide SOLUTION 200 MG/ML ORAL |
| HIC3 | H1I |
| HIC3 Description | GLYPROMATE (GPE) ANALOGS |
| GCN | 53839 |
| HICL Sequence Number | 048773 |
| HICL Sequence Number Description | TROFINETIDE |
| Brand/Generic | Brand |
| Proprietary Name | Daybue |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | trofinetide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mg/mL |
| Substance Name | TROFINETIDE |
| Labeler Name | Acadia Pharmaceuticals Inc. |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA217026 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 63090-0660-01 (63090066001)
| NDC Package Code | 63090-660-01 |
|---|---|
| Billing NDC | 63090066001 |
| Package | 1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2022-12-31 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |