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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N216540-001ATTRUBYACORAMIDIS HYDROCHLORIDEEQ 356MG BASETABLET / ORALRLD, RS2024-11-22

Orange Book patents#

Current patent rows page 1 of 1 · 13 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N216540-001103986812031-05-05Drug product2024-12-18
N216540-001108427772031-05-05U-40462024-12-18
N216540-00188777952031-05-05Drug product2024-12-18
N216540-00191692142031-05-05U-4046Drug product2024-12-18
N216540-00196428382031-05-05Drug substance, Drug product2024-12-18
N216540-00199138262031-05-05U-40462024-12-18
N216540-001105134972038-02-16Drug substance2024-12-18
N216540-001119198652038-02-16U-40462024-12-18
N216540-001110586682039-03-22U-40462024-12-18
N216540-001120704492039-03-22U-40462024-12-18
N216540-001112600472039-08-16Drug product2024-12-18
N216540-001120050432039-08-16U-4046Drug product2024-12-18
N216540-001125392902039-08-16Drug product2026-02-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N216540-001NCE2029-11-22
N216540-001ODE-5062031-11-22

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-2284e616aacf4f…
2026-08-18 06:07:402026-07N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-222680178bc6a6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216540-001ATTRUBYEQ 356MG BASETABLET / ORALRLD, RS2024-11-22a50c72e98297…

Observed Orange Book patent history#

Patent history page 1 of 3 · 111 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N216540-001103986812031-05-05Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001108427772031-05-05U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00188777952031-05-05Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00191692142031-05-05U-4046Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00196428382031-05-05Drug substance, Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-00199138262031-05-05U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001105134972038-02-16Drug substance2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001119198652038-02-16U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001110586682039-03-22U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001120704492039-03-22U-40462024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001112600472039-08-16Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001120050432039-08-16U-4046Drug product2024-12-1884e616aacf4f…
2026-09-14 22:38:342026-08N216540-001125392902039-08-16Drug product2026-02-2784e616aacf4f…
2026-08-18 06:07:402026-07N216540-001103986812031-05-05Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001108427772031-05-05U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00188777952031-05-05Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00191692142031-05-05U-4046Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00196428382031-05-05Drug substance, Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-00199138262031-05-05U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001105134972038-02-16Drug substance2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001119198652038-02-16U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001110586682039-03-22U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001120704492039-03-22U-40462024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001112600472039-08-16Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001120050432039-08-16U-4046Drug product2024-12-18caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001125392902039-08-16Drug product2026-02-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216540-001103986812031-05-05Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001108427772031-05-05U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00188777952031-05-05Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00191692142031-05-05U-4046Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00196428382031-05-05Drug substance, Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-00199138262031-05-05U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001105134972038-02-16Drug substance2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001119198652038-02-16U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001110586682039-03-22U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001120704492039-03-22U-40462024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001112600472039-08-16Drug product2024-12-18011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001120050432039-08-16U-4046Drug product2024-12-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001103986812031-05-05Drug product2024-12-1831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001108427772031-05-05U-40462024-12-1831067a03dcf5…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-09-14 22:38:342026-08N216540-001NCE2029-11-2284e616aacf4f…
2026-09-14 22:38:342026-08N216540-001ODE-5062031-11-2284e616aacf4f…
2026-08-18 06:07:402026-07N216540-001NCE2029-11-22caaa826d4ba7…
2026-08-18 06:07:402026-07N216540-001ODE-5062031-11-22caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N216540-001NCE2029-11-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N216540-001ODE-5062031-11-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001NCE2029-11-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N216540-001ODE-5062031-11-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08N216540-001NCE2029-11-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N216540-001ODE-5062031-11-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216540-001NCE2029-11-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N216540-001ODE-5062031-11-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216540-001NCE2029-11-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N216540-001ODE-5062031-11-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N216540-001NCE2029-11-2203ed91905a0d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216540-001NCE2029-11-22a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N216540-001ODE-5062031-11-22a50c72e98297…

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
IngredientStrength
ACORAMIDIS HYDROCHLORIDE356 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
VY9C88C2NVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2698318Internal RxNorm lookup
2698324Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
913552ef-875d-4cb7-bf05-a7d20a394c38Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dee90427-e65f-4b9e-bc0e-ea56ed8f6b7dProduct name120250729

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82228-712-28Attruby4 in 1 CARTONTABLET, FILM COATED46
82228-712-28Attruby1 in 1 DOSE PACKTABLET, FILM COATED16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82228-712-28EA - Each82228-71245566165-12a2-4520-8788-c96a5d9fdc5012024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82228-712ATTRUBY (ACORAMIDIS HYDROCHLORIDE) TABLET, FILM COATED [BRIDGEBIO PHARMA, INC.]3Current NDC, 2 package rows20250515_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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AttrubyACORAMIDIS HYDROCHLORIDEBridgeBio Pharma, Inc.913552ef-875d-4cb7-bf05-a7d20a394c382026-06-29Adverse reactionsExact identifier
application applno (NDA): 216540
application number: NDA216540
ndc (package): 82228-712-28
ndc (product): 82228-712
ndc11 (package): 82228071228

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2698318acoramidis 356 MG Oral TabletPSN913552ef-875d-4cb7-bf05-a7d20a394c386
2698324Attruby 356 MG Oral TabletPSN913552ef-875d-4cb7-bf05-a7d20a394c386
2698324acoramidis 356 MG Oral Tablet [Attruby]SBD913552ef-875d-4cb7-bf05-a7d20a394c386
2698318acoramidis 356 MG Oral TabletSCD913552ef-875d-4cb7-bf05-a7d20a394c386
2698318acoramidis 356 MG (as acoramidis hydrochloride 400 MG) Oral TabletSY913552ef-875d-4cb7-bf05-a7d20a394c386
2698324Attruby 356 MG Oral TabletSY913552ef-875d-4cb7-bf05-a7d20a394c386

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82228-712-28822280712284 DOSE PACK in 1 CARTON (82228-712-28) / 1 BLISTER PACK in 1 DOSE PACK / 28 TABLET, FILM COATED in 1 BLISTER PACK4 dose pack2024-11-22NoNoCurrent