MYQORZO

Product NDC
82112-115
11-digit product format
821120115
Labeler code
82112
Product ID
82112-115_f48908e6-f578-4e6c-b4ac-d4af4f01fdd6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AFICAMTEN
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Cytokinetics Inc.
Application
NDA219083
Marketing category
NDA
Marketing start
2026-01-12
Substance
AFICAMTEN
Active strength
15 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AFICAMTEN15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB1I77MH6K1
Rxcui2731474, 2731480, 2731482, 2731484, 2731486, 2731488, 2731490, 2731492

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82112-115-30MYQORZO30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82112-115-30EA - Each82112-115f0895afd-9fe2-4df1-9ddf-98ba39590edb12026-02-05

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82112-115-308211201153030 TABLET, FILM COATED in 1 BOTTLE (82112-115-30) 2026-01-12NoNoHistorical