daybue stix

Generic: trofinetide

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

Drug Facts

Product Profile

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

trofinetide 8000 mg/1

Manufacturer
Acadia Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 63090-665
Product ID 63090-665_112aedcc-d2e7-406d-94ea-ddaceeee6b72
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA219884
Listing Expiration 2026-12-31
Marketing Start 2025-12-11

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 63090665
Hyphenated Format 63090-665

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 stix (source: ndc)
Generic Name trofinetide (source: ndc)
Application Number NDA219884 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8000 mg/1
source: ndc
Packaging
  • 60 PACKET in 1 CARTON (63090-665-60) / 1 FOR SOLUTION in 1 PACKET (63090-665-01)
source: ndc

Packages (1)

Ingredients (1)

trofinetide (8000 mg/1)

Linked Drug Pages (1)

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": "60 PACKET in 1 CARTON (63090-665-60)  / 1 FOR SOLUTION in 1 PACKET (63090-665-01)", "package_ndc": "63090-665-60", "marketing_start_date": "20251211"}], "brand_name": "Daybue Stix", "product_id": "63090-665_112aedcc-d2e7-406d-94ea-ddaceeee6b72", "dosage_form": "FOR SOLUTION", "pharm_class": ["Cytochrome P450 3A4 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA]", "Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]"], "product_ndc": "63090-665", "generic_name": "trofinetide", "labeler_name": "Acadia Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Daybue Stix", "active_ingredients": [{"name": "TROFINETIDE", "strength": "8000 mg/1"}], "application_number": "NDA219884", "marketing_category": "NDA", "marketing_start_date": "20251211", "listing_expiration_date": "20261231"}