daybue

Generic: trofinetide

Labeler: acadia pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name daybue
Generic Name trofinetide
Labeler acadia pharmaceuticals inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

trofinetide 200 mg/mL

Manufacturer
Acadia Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 63090-660
Product ID 63090-660_112aedcc-d2e7-406d-94ea-ddaceeee6b72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA217026
Listing Expiration 2026-12-31
Marketing Start 2023-03-10

Pharmacologic Class

Mechanism of Action
cytochrome p450 3a4 inhibitors [moa] organic anion transporting polypeptide 1b1 inhibitors [moa] organic anion transporting polypeptide 1b3 inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63090660
Hyphenated Format 63090-660

Supplemental Identifiers

RxCUI
2632857 2632863 2729447 2729451 2729453 2729455 2729457 2729459
UPC
0363090660012
UNII
Z2ME8F52QL
NUI
N0000182141 N0000190107 N0000190108

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name daybue (source: ndc)
Generic Name trofinetide (source: ndc)
Application Number NDA217026 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 200 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC
source: ndc

Packages (1)

63090-660-01 1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC

Ingredients (1)

trofinetide (200 mg/mL)

Linked Drug Pages (1)

Daybue, Daybue Stix ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "112aedcc-d2e7-406d-94ea-ddaceeee6b72", "openfda": {"nui": ["N0000182141", "N0000190107", "N0000190108"], "upc": ["0363090660012"], "unii": ["Z2ME8F52QL"], "rxcui": ["2632857", "2632863", "2729447", "2729451", "2729453", "2729455", "2729457", "2729459"], "spl_set_id": ["67e6f2d9-21f6-466f-9def-826c6a4b8257"], "pharm_class_moa": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]"], "manufacturer_name": ["Acadia Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01)  / 450 mL in 1 BOTTLE, PLASTIC", "package_ndc": "63090-660-01", "marketing_start_date": "20230310"}], "brand_name": "Daybue", "product_id": "63090-660_112aedcc-d2e7-406d-94ea-ddaceeee6b72", "dosage_form": "SOLUTION", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]"], "product_ndc": "63090-660", "generic_name": "trofinetide", "labeler_name": "Acadia Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daybue", "active_ingredients": [{"name": "TROFINETIDE", "strength": "200 mg/mL"}], "application_number": "NDA217026", "marketing_category": "NDA", "marketing_start_date": "20230310", "listing_expiration_date": "20261231"}