MYQORZO

Product NDC: 82112-115
Requested package NDC: 82112-115-30
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

Orange Book products#

Current product rows page 1 of 1 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219083-001	MYQORZO	AFICAMTEN	5MG	TABLET / ORAL	RLD, RS	2025-12-19
N219083-002	MYQORZO	AFICAMTEN	10MG	TABLET / ORAL	RLD	2025-12-19
N219083-003	MYQORZO	AFICAMTEN	15MG	TABLET / ORAL	RLD	2025-12-19
N219083-004	MYQORZO	AFICAMTEN	20MG	TABLET / ORAL	RLD	2025-12-19

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
N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-001	12370179	2042-07-15	U-4371		2026-01-13
N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-002	12370179	2042-07-15	U-4371		2026-01-13
N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-003	12370179	2042-07-15	U-4371		2026-01-13
N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13
N219083-004	12370179	2042-07-15	U-4371		2026-01-13

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 4 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219083-001	NCE	2030-12-19
N219083-002	NCE	2030-12-19
N219083-003	NCE	2030-12-19
N219083-004	NCE	2030-12-19

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	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	MYQORZO	5MG	TABLET / ORAL	RLD, RS	2025-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	MYQORZO	10MG	TABLET / ORAL	RLD	2025-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	MYQORZO	15MG	TABLET / ORAL	RLD	2025-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	MYQORZO	20MG	TABLET / ORAL	RLD	2025-12-19	`a50c72e98297…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-10-15 13:18:30	2026-09	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	10836755	2039-01-18	U-4371	Drug substance, Drug product	2026-01-13	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	12370179	2042-07-15	U-4371		2026-01-13	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-10-15 13:18:30	2026-09	N219083-001	NCE	2030-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-002	NCE	2030-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-003	NCE	2030-12-19	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N219083-004	NCE	2030-12-19	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N219083-001	NCE	2030-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-002	NCE	2030-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-003	NCE	2030-12-19	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219083-004	NCE	2030-12-19	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219083-001	NCE	2030-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-002	NCE	2030-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-003	NCE	2030-12-19	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219083-004	NCE	2030-12-19	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219083-001	NCE	2030-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-002	NCE	2030-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-003	NCE	2030-12-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219083-004	NCE	2030-12-19	`011fe1cb6892…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-001	NCE	2030-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-002	NCE	2030-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-003	NCE	2030-12-19	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219083-004	NCE	2030-12-19	`a50c72e98297…`

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: MYQORZO
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
AFICAMTEN	15 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
B1I77MH6K1	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2731474	Internal RxNorm lookup
2731480	Internal RxNorm lookup
2731482	Internal RxNorm lookup
2731484	Internal RxNorm lookup
2731486	Internal RxNorm lookup
2731488	Internal RxNorm lookup
2731490	Internal RxNorm lookup
2731492	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
fd778507-1274-4d1a-a659-5431d55c543a	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82112-115-30	MYQORZO	30 in 1 BOTTLE	TABLET, FILM COATED	30		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82112-115-30	EA - Each	82112-115	f0895afd-9fe2-4df1-9ddf-98ba39590edb	1	2026-02-05

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MYQORZO	AFICAMTEN	Cytokinetics Inc.	fd778507-1274-4d1a-a659-5431d55c543a	2025-12-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 219083 application number: NDA219083 ndc (package): 82112-115-30 ndc (product): 82112-115 ndc11 (package): 82112011530

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2731474	aficamten 10 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731486	aficamten 15 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731490	aficamten 20 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731482	aficamten 5 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731480	Myqorzo 10 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731488	Myqorzo 15 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731492	Myqorzo 20 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731484	Myqorzo 5 MG Oral Tablet	PSN	fd778507-1274-4d1a-a659-5431d55c543a	2
2731480	aficamten 10 MG Oral Tablet [Myqorzo]	SBD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731488	aficamten 15 MG Oral Tablet [Myqorzo]	SBD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731492	aficamten 20 MG Oral Tablet [Myqorzo]	SBD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731484	aficamten 5 MG Oral Tablet [Myqorzo]	SBD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731474	aficamten 10 MG Oral Tablet	SCD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731486	aficamten 15 MG Oral Tablet	SCD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731490	aficamten 20 MG Oral Tablet	SCD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731482	aficamten 5 MG Oral Tablet	SCD	fd778507-1274-4d1a-a659-5431d55c543a	2
2731480	Myqorzo 10 MG Oral Tablet	SY	fd778507-1274-4d1a-a659-5431d55c543a	2
2731488	Myqorzo 15 MG Oral Tablet	SY	fd778507-1274-4d1a-a659-5431d55c543a	2
2731492	Myqorzo 20 MG Oral Tablet	SY	fd778507-1274-4d1a-a659-5431d55c543a	2
2731484	Myqorzo 5 MG Oral Tablet	SY	fd778507-1274-4d1a-a659-5431d55c543a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82112-115-30	82112011530	30 TABLET, FILM COATED in 1 BOTTLE (82112-115-30)	2026-01-12	No	No	Current