Daybue Stix

Product NDC
63090-664
11-digit product format
630900664
Labeler code
63090
Product ID
63090-664_acf4551a-4f21-46d6-8575-0c553c2c6d39
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
6000 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N219884-001DAYBUE STIXTROFINETIDE5000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11
N219884-002DAYBUE STIXTROFINETIDE6000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11
N219884-003DAYBUE STIXTROFINETIDE8000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11

Orange Book patents#

Current patent rows page 1 of 1 · 24 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N219884-00192122042032-01-27U-35562026-01-08
N219884-0019212204*PED2032-07-27Pediatric extension
N219884-001113707552040-08-03Drug substance, Drug product2026-01-08
N219884-00111370755*PED2041-02-03Pediatric extension
N219884-001118276002042-07-12U-3556Drug substance, Drug product2026-01-08
N219884-001124921672042-07-12U-3556Drug substance, Drug product2026-01-08
N219884-00111827600*PED2043-01-12Pediatric extension
N219884-00112492167*PED2043-01-12Pediatric extension
N219884-00292122042032-01-27U-35562026-01-08
N219884-0029212204*PED2032-07-27Pediatric extension
N219884-002113707552040-08-03Drug substance, Drug product2026-01-08
N219884-00211370755*PED2041-02-03Pediatric extension
N219884-002118276002042-07-12U-3556Drug substance, Drug product2026-01-08
N219884-002124921672042-07-12U-3556Drug substance, Drug product2026-01-08
N219884-00211827600*PED2043-01-12Pediatric extension
N219884-00212492167*PED2043-01-12Pediatric extension
N219884-00392122042032-01-27U-35562026-01-08
N219884-0039212204*PED2032-07-27Pediatric extension
N219884-003113707552040-08-03Drug substance, Drug product2026-01-08
N219884-00311370755*PED2041-02-03Pediatric extension
N219884-003118276002042-07-12U-3556Drug substance, Drug product2026-01-08
N219884-003124921672042-07-12U-3556Drug substance, Drug product2026-01-08
N219884-00311827600*PED2043-01-12Pediatric extension
N219884-00312492167*PED2043-01-12Pediatric extension

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N219884-001NCE2028-03-10
N219884-001PED2028-09-10
N219884-001ODE*2030-03-10
N219884-001PED2030-09-10
N219884-002NCE2028-03-10
N219884-002PED2028-09-10
N219884-002ODE*2030-03-10
N219884-002PED2030-09-10
N219884-003NCE2028-03-10
N219884-003PED2028-09-10
N219884-003ODE*2030-03-10
N219884-003PED2030-09-10

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N219884-001DAYBUE STIX5000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-1184e616aacf4f…
2026-09-14 22:38:342026-08N219884-002DAYBUE STIX6000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-1184e616aacf4f…
2026-09-14 22:38:342026-08N219884-003DAYBUE STIX8000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-1184e616aacf4f…
2026-08-18 06:07:402026-07N219884-001DAYBUE STIX5000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002DAYBUE STIX6000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-003DAYBUE STIX8000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219884-001DAYBUE STIX5000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219884-002DAYBUE STIX6000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219884-003DAYBUE STIX8000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-001DAYBUE STIX5000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-002DAYBUE STIX6000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-003DAYBUE STIX8000MG/PACKETFOR SOLUTION / ORALRLD, RS2025-12-11a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N219884-00192122042032-01-27U-35562026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-0019212204*PED2032-07-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-001113707552040-08-03Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-00111370755*PED2041-02-03Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-001118276002042-07-12U-3556Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-001124921672042-07-12U-3556Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-00111827600*PED2043-01-12Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-00112492167*PED2043-01-12Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-00292122042032-01-27U-35562026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-0029212204*PED2032-07-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-002113707552040-08-03Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-00211370755*PED2041-02-03Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-002118276002042-07-12U-3556Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-002124921672042-07-12U-3556Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-00211827600*PED2043-01-12Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-00212492167*PED2043-01-12Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-00392122042032-01-27U-35562026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-0039212204*PED2032-07-27Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-003113707552040-08-03Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-00311370755*PED2041-02-03Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-003118276002042-07-12U-3556Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-003124921672042-07-12U-3556Drug substance, Drug product2026-01-0884e616aacf4f…
2026-09-14 22:38:342026-08N219884-00311827600*PED2043-01-12Pediatric extension84e616aacf4f…
2026-09-14 22:38:342026-08N219884-00312492167*PED2043-01-12Pediatric extension84e616aacf4f…
2026-08-18 06:07:402026-07N219884-00192122042032-01-27U-35562026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-0019212204*PED2032-07-27Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N219884-001113707552040-08-03Drug substance, Drug product2026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-00111370755*PED2041-02-03Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N219884-001118276002042-07-12U-3556Drug substance, Drug product2026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-001124921672042-07-12U-3556Drug substance, Drug product2026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-00111827600*PED2043-01-12Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N219884-00112492167*PED2043-01-12Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N219884-00292122042032-01-27U-35562026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-0029212204*PED2032-07-27Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002113707552040-08-03Drug substance, Drug product2026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-00211370755*PED2041-02-03Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002118276002042-07-12U-3556Drug substance, Drug product2026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002124921672042-07-12U-3556Drug substance, Drug product2026-01-08caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-00211827600*PED2043-01-12Pediatric extensioncaaa826d4ba7…
2026-08-18 06:07:402026-07N219884-00212492167*PED2043-01-12Pediatric extensioncaaa826d4ba7…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N219884-001NCE2028-03-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-001PED2028-09-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-001ODE*2030-03-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-001PED2030-09-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-002NCE2028-03-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-002PED2028-09-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-002ODE*2030-03-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-002PED2030-09-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-003NCE2028-03-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-003PED2028-09-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-003ODE*2030-03-1084e616aacf4f…
2026-09-14 22:38:342026-08N219884-003PED2030-09-1084e616aacf4f…
2026-08-18 06:07:402026-07N219884-001NCE2028-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-001PED2028-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-001ODE*2030-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-001PED2030-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002NCE2028-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002PED2028-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002ODE*2030-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-002PED2030-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-003NCE2028-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-003PED2028-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-003ODE*2030-03-10caaa826d4ba7…
2026-08-18 06:07:402026-07N219884-003PED2030-09-10caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N219884-001NCE2028-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219884-001ODE*2030-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219884-002NCE2028-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219884-002ODE*2030-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219884-003NCE2028-03-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N219884-003ODE*2030-03-10011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-001NCE2028-03-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-001PED2028-09-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-001ODE*2030-03-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-001PED2030-09-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-002NCE2028-03-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-002PED2028-09-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-002ODE*2030-03-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-002PED2030-09-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-003NCE2028-03-10a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N219884-003PED2028-09-10a50c72e98297…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TROFINETIDE6000 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z2ME8F52QLInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2632857Internal RxNorm lookup
2632863Internal RxNorm lookup
2729447Internal RxNorm lookup
2729451Internal RxNorm lookup
2729453Internal RxNorm lookup
2729455Internal RxNorm lookup
2729457Internal RxNorm lookup
2729459Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
67e6f2d9-21f6-466f-9def-826c6a4b8257Available on FDA.report

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
63090-664-01Daybue Stix1 in 1 PACKETFOR SOLUTION110
63090-664-60Daybue Stix60 in 1 CARTONFOR SOLUTION6010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63090-664-01EA - Each63090-6648101eb9f-f7c4-4a99-ae54-c3b75d4ab39b12026-02-05
63090-664-60EA - Each63090-664f26242d7-db7a-43ac-be2a-3589eccfdfe512026-02-05

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DaybueTROFINETIDEAcadia Pharmaceuticals Inc.67e6f2d9-21f6-466f-9def-826c6a4b82572026-09-04Warnings, Adverse reactionsExact identifier
application applno (NDA): 219884
application number: NDA219884
ndc (product): 63090-664

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
63090-664-01630900664011 in 1 PACKETHistorical
63090-664-606309006646060 PACKET in 1 CARTON (63090-664-60) / 1 FOR SOLUTION in 1 PACKET (63090-664-01) 60 packet2025-12-11NoNoCurrent