Home NDC 82228-712-28 Attruby
Product NDC 82228-712
Requested package NDC 82228-712-28
11-digit product format 822280712
Labeler code 82228
Product ID 82228-712_c0fcfa4c-0b57-4260-839e-51171b7f1baa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name acoramidis hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler BridgeBio Pharma, Inc.
Application NDA216540
Marketing category NDA
Marketing start 2024-11-22
Substance ACORAMIDIS HYDROCHLORIDE
Active strength 356 mg/1
Pharmacologic classes Cytochrome P450 2C9 Inhibitors [MoA], Transthyretin Stabilizer [EPC], Transthyretin Stabilizers [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 N216540-001 ATTRUBY ACORAMIDIS HYDROCHLORIDE EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22
Orange Book patents# Current patent rows page 1 of 1 · 13 matching rows.
Application-product, Patent, Expiration table Application-product Patent Expiration Use code Coverage / status Submission date N216540-001 10398681 2031-05-05 Drug product 2024-12-18 N216540-001 10842777 2031-05-05 U-4046 2024-12-18 N216540-001 8877795 2031-05-05 Drug product 2024-12-18 N216540-001 9169214 2031-05-05 U-4046 Drug product 2024-12-18 N216540-001 9642838 2031-05-05 Drug substance, Drug product 2024-12-18 N216540-001 9913826 2031-05-05 U-4046 2024-12-18 N216540-001 10513497 2038-02-16 Drug substance 2024-12-18 N216540-001 11919865 2038-02-16 U-4046 2024-12-18 N216540-001 11058668 2039-03-22 U-4046 2024-12-18 N216540-001 12070449 2039-03-22 U-4046 2024-12-18 N216540-001 11260047 2039-08-16 Drug product 2024-12-18 N216540-001 12005043 2039-08-16 U-4046 Drug product 2024-12-18 N216540-001 12539290 2039-08-16 Drug product 2026-02-27
Orange Book exclusivity# Current exclusivity rows page 1 of 1 · 2 matching rows.
Application-product, Exclusivity code, Expiration table Application-product Exclusivity code Expiration N216540-001 NCE 2029-11-22 N216540-001 ODE-506 2031-11-22
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 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 2680178bc6a6…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 N216540-001 ATTRUBY EQ 356MG BASE TABLET / ORAL RLD, RS 2024-11-22 a50c72e98297…
Observed Orange Book patent history# Patent history page 1 of 3 · 111 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 N216540-001 10398681 2031-05-05 Drug product 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 10842777 2031-05-05 U-4046 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 8877795 2031-05-05 Drug product 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 9169214 2031-05-05 U-4046 Drug product 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 9642838 2031-05-05 Drug substance, Drug product 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 9913826 2031-05-05 U-4046 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 10513497 2038-02-16 Drug substance 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 11919865 2038-02-16 U-4046 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 11058668 2039-03-22 U-4046 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 12070449 2039-03-22 U-4046 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 11260047 2039-08-16 Drug product 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 12005043 2039-08-16 U-4046 Drug product 2024-12-18 84e616aacf4f…2026-09-14 22:38:34 2026-08 N216540-001 12539290 2039-08-16 Drug product 2026-02-27 84e616aacf4f…2026-08-18 06:07:40 2026-07 N216540-001 10398681 2031-05-05 Drug product 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 10842777 2031-05-05 U-4046 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 8877795 2031-05-05 Drug product 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 9169214 2031-05-05 U-4046 Drug product 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 9642838 2031-05-05 Drug substance, Drug product 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 9913826 2031-05-05 U-4046 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 10513497 2038-02-16 Drug substance 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 11919865 2038-02-16 U-4046 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 11058668 2039-03-22 U-4046 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 12070449 2039-03-22 U-4046 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 11260047 2039-08-16 Drug product 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 12005043 2039-08-16 U-4046 Drug product 2024-12-18 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N216540-001 12539290 2039-08-16 Drug product 2026-02-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N216540-001 10398681 2031-05-05 Drug product 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 10842777 2031-05-05 U-4046 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 8877795 2031-05-05 Drug product 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 9169214 2031-05-05 U-4046 Drug product 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 9642838 2031-05-05 Drug substance, Drug product 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 9913826 2031-05-05 U-4046 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 10513497 2038-02-16 Drug substance 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 11919865 2038-02-16 U-4046 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 11058668 2039-03-22 U-4046 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 12070449 2039-03-22 U-4046 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 11260047 2039-08-16 Drug product 2024-12-18 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N216540-001 12005043 2039-08-16 U-4046 Drug product 2024-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216540-001 10398681 2031-05-05 Drug product 2024-12-18 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N216540-001 10842777 2031-05-05 U-4046 2024-12-18 31067a03dcf5…
Observed Orange Book exclusivity history# 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 Attruby
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACORAMIDIS HYDROCHLORIDE 356 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination VY9C88C2NV Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2698318 Internal RxNorm lookup 2698324 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 82228-712-28 Attruby 4 in 1 CARTON TABLET, FILM COATED 4 6 82228-712-28 Attruby 1 in 1 DOSE PACK TABLET, FILM COATED 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82228-712 ATTRUBY (ACORAMIDIS HYDROCHLORIDE) TABLET, FILM COATED [BRIDGEBIO PHARMA, INC.] 3 Current NDC, 2 package rows 20250515_913552ef-875d-4cb7-bf05-a7d20a394c38.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 Units Marketing start Sample Exclude flag Status 82228-712-28 82228071228 4 DOSE PACK in 1 CARTON (82228-712-28) / 1 BLISTER PACK in 1 DOSE PACK / 28 TABLET, FILM COATED in 1 BLISTER PACK 4 dose pack 2024-11-22 No No Current