FDA.reportPublic FDA data

Daybue

Product NDC
63090-660
11-digit product format
630900660
Labeler code
63090
Product ID
63090-660_d88ad1a8-3656-4de5-811a-bcebb0c76567
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trofinetide
Dosage form
SOLUTION
Route
ORAL
Labeler
Acadia Pharmaceuticals Inc.
Application
NDA217026
Marketing category
NDA
Marketing start
2023-03-10
Substance
TROFINETIDE
Active strength
200 mg/mL
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROFINETIDE200 mg/mL

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
63090-660-01Daybue1 in 1 CARTONSOLUTION110
63090-660-01Daybue450 mL in 1 BOTTLE, PLASTICSOLUTION45010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63090-660-01ML - Milliliter63090-660273d6930-2915-4296-a0ca-bfc5c2a8343e12023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63090-660DAYBUE (TROFINETIDE) SOLUTION [ACADIA PHARMACEUTICALS INC.]5Current NDC, 2 package rows20250207_67e6f2d9-21f6-466f-9def-826c6a4b8257.zip

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 formatDescriptionMarketing startSampleExclude flagStatus
63090-660-01630900660011 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC2023-03-10NoNoHistorical