FDA.reportPublic FDA data

Daybue Stix

Product NDC
63090-665
11-digit product format
630900665
Labeler code
63090
Product ID
63090-665_d88ad1a8-3656-4de5-811a-bcebb0c76567
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trofinetide
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
Acadia Pharmaceuticals Inc.
Application
NDA219884
Marketing category
NDA
Marketing start
2025-12-11
Substance
TROFINETIDE
Active strength
8000 mg/1
Pharmacologic classes
Cytochrome P450 3A4 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B1 Inhibitors [MoA], Organic Anion Transporting Polypeptide 1B3 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Daybue Stix
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROFINETIDE8000 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ2ME8F52QL
Rxcui2632857, 2632863, 2729447, 2729451, 2729453, 2729455, 2729457, 2729459

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5a89df4d-ec1c-4e0a-a7c1-79cebf0866c2Product name120231005

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63090-665-01Daybue Stix1 in 1 PACKETFOR SOLUTION110
63090-665-60Daybue Stix60 in 1 CARTONFOR SOLUTION6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63090-665-01EA - Each63090-6652a1222b2-9b4a-47d3-b31a-aa5dcc3c31e312026-02-05
63090-665-60EA - Each63090-665bc674247-70fe-408d-8355-cff6e434198412026-02-05

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2632863Daybue 200 MG/mL Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2729451Daybue Stix 5000 MG Powder for Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2729455Daybue Stix 6000 MG Powder for Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2729459Daybue Stix 8000 MG Powder for Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2632857trofinetide 200 MG/mL Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2729447trofinetide 5000 MG Powder for Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2729453trofinetide 6000 MG Powder for Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2729457trofinetide 8000 MG Powder for Oral SolutionPSN67e6f2d9-21f6-466f-9def-826c6a4b825710
2632863trofinetide 200 MG/ML Oral Solution [Daybue]SBD67e6f2d9-21f6-466f-9def-826c6a4b825710
2729451trofinetide 5000 MG Powder for Oral Solution [Daybue]SBD67e6f2d9-21f6-466f-9def-826c6a4b825710
2729455trofinetide 6000 MG Powder for Oral Solution [Daybue]SBD67e6f2d9-21f6-466f-9def-826c6a4b825710
2729459trofinetide 8000 MG Powder for Oral Solution [Daybue]SBD67e6f2d9-21f6-466f-9def-826c6a4b825710
2632857trofinetide 200 MG/ML Oral SolutionSCD67e6f2d9-21f6-466f-9def-826c6a4b825710
2729447trofinetide 5000 MG Powder for Oral SolutionSCD67e6f2d9-21f6-466f-9def-826c6a4b825710
2729453trofinetide 6000 MG Powder for Oral SolutionSCD67e6f2d9-21f6-466f-9def-826c6a4b825710
2729457trofinetide 8000 MG Powder for Oral SolutionSCD67e6f2d9-21f6-466f-9def-826c6a4b825710
2632863Daybue 200 MG/ML Oral SolutionSY67e6f2d9-21f6-466f-9def-826c6a4b825710
2729451Daybue 5000 MG Powder for Oral SolutionSY67e6f2d9-21f6-466f-9def-826c6a4b825710
2729455Daybue 6000 MG Powder for Oral SolutionSY67e6f2d9-21f6-466f-9def-826c6a4b825710
2729459Daybue 8000 MG Powder for Oral SolutionSY67e6f2d9-21f6-466f-9def-826c6a4b825710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63090-665-01630900665011 in 1 PACKETHistorical
63090-665-606309006656060 PACKET in 1 CARTON (63090-665-60) / 1 FOR SOLUTION in 1 PACKET (63090-665-01) 60 packet2025-12-11NoNoHistorical