FDA.reportPublic FDA data

Attruby

Product NDC
82228-712
11-digit product format
822280712
Labeler code
82228
Product ID
82228-712_28373fa9-eaed-4941-9b38-89ebe785c2d6
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Attruby
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACORAMIDIS HYDROCHLORIDE356 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiVY9C88C2NV
Rxcui2698318, 2698324

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82228-712-282025-08-07C16284748780-13b156c62-282e-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use ATTRUBY safely and effectively. See full prescribing information for ATTRUBY. ATTRUBY ™ (acoramidis) tablets, for oral administration, Initial U.S. Approval: 2024
82228-712-282025-07-29C16284748780-13b156c62-282e-fb37-e063-e6dba90a4e07These highlights do not include all the information needed to use ATTRUBY safely and effectively. See full prescribing information for ATTRUBY. ATTRUBY ™ (acoramidis) tablets, for oral administration, Initial U.S. Approval: 2024

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

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 pack2024-11-22NoNoHistorical