Home NDC 63090-660 Daybue
Product NDC 63090-660
11-digit product format 630900660
Labeler code 63090
Product ID 63090-660_acf4551a-4f21-46d6-8575-0c553c2c6d39
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 Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N217026-001 DAYBUE TROFINETIDE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10
Orange Book patents# Current patent rows page 1 of 1 · 8 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N217026-001 9212204 2032-01-27 U-3556 2023-04-07 N217026-001 9212204*PED 2032-07-27 Pediatric extension N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 N217026-001 11370755*PED 2041-02-03 Pediatric extension N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 N217026-001 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 N217026-001 11827600*PED 2043-01-12 Pediatric extension N217026-001 12492167*PED 2043-01-12 Pediatric extension
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 4 matching rows.
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 Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N217026-001 DAYBUE 200MG/ML SOLUTION / ORAL RLD, RS 2023-03-10 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 2 · 79 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2026-09-14 22:38:34 2026-08 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217026-001 9212204*PED 2032-07-27 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217026-001 11370755*PED 2041-02-03 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217026-001 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217026-001 11827600*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-09-14 22:38:34 2026-08 N217026-001 12492167*PED 2043-01-12 Pediatric extension 84e616aacf4f…2026-08-18 06:07:40 2026-07 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217026-001 9212204*PED 2032-07-27 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217026-001 11370755*PED 2041-02-03 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217026-001 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217026-001 11827600*PED 2043-01-12 Pediatric extension caaa826d4ba7…2026-08-18 06:07:40 2026-07 N217026-001 12492167*PED 2043-01-12 Pediatric extension caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N217026-001 12492167 2042-07-12 U-3556 Drug substance, Drug product 2026-01-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N217026-001 11827600 2042-07-12 U-3556 Drug substance, Drug product 2024-08-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217026-001 9212204 2032-01-27 U-3556 2023-04-07 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N217026-001 11370755 2040-08-03 Drug substance, Drug product 2023-04-07 5bbf6a4d5a75…
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 55 observed states.
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TROFINETIDE 200 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z2ME8F52QL Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 8 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2632857 Internal RxNorm lookup 2632863 Internal RxNorm lookup 2729447 Internal RxNorm lookup 2729451 Internal RxNorm lookup 2729453 Internal RxNorm lookup 2729455 Internal RxNorm lookup 2729457 Internal RxNorm lookup 2729459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63090-660-01 Daybue 1 in 1 CARTON SOLUTION 1 10 63090-660-01 Daybue 450 mL in 1 BOTTLE, PLASTIC SOLUTION 450 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63090-660 DAYBUE (TROFINETIDE) SOLUTION [ACADIA PHARMACEUTICALS INC.] 5 Current NDC, 2 package rows 20250207_67e6f2d9-21f6-466f-9def-826c6a4b8257.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 63090-660-01 63090066001 1 BOTTLE, PLASTIC in 1 CARTON (63090-660-01) / 450 mL in 1 BOTTLE, PLASTIC 2023-03-10 No No Current