Gomekli

Product NDC: 82448-134
Requested package NDC: 82448-134-84
11-digit product format: 824480134
Labeler code: 82448
Product ID: 82448-134_5132f76b-c3da-4831-833c-c48cb8eee26a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: mirdametinib
Dosage form: TABLET, FOR SUSPENSION
Route: ORAL
Labeler: SpringWorks Therapeutics, Inc.
Application: NDA219379
Marketing category: NDA
Marketing start: 2025-02-11
Substance: MIRDAMETINIB
Active strength: 1 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Mitogen-Activated Protein Kinase Kinase 1 Inhibitors [MoA], Mitogen-Activated Protein Kinase Kinase 2 Inhibitors [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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N219379-001	GOMEKLI	MIRDAMETINIB	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11
N219379-002	GOMEKLI	MIRDAMETINIB	3MG	TABLET, FOR SUSPENSION / ORAL	RLD	2026-07-28
N219379-003	GOMEKLI	MIRDAMETINIB	4MG	TABLET, FOR SUSPENSION / ORAL	RLD	2026-07-28

Orange Book patents#

Current patent rows page 1 of 1 · 53 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N219379-001	11066358	2041-02-17		Drug substance	2025-02-14
N219379-001	11084780	2041-02-17		Drug substance	2025-02-14
N219379-001	11453641	2041-02-17	U-4130		2025-02-14
N219379-001	11571402	2041-02-17		Drug product	2025-02-14
N219379-001	11806321	2041-02-17	U-4130		2025-02-14
N219379-001	11819487	2041-02-17	U-4590		2025-02-14
N219379-001	12011424	2041-02-17	U-4595		2025-02-14
N219379-001	12037306	2041-02-17	U-4130		2025-02-14
N219379-001	12090128	2041-02-17	U-4130	Drug product	2025-02-14
N219379-001	12263146	2041-02-17	U-4130		2025-04-03
N219379-001	12295925	2041-02-17	U-4590		2025-05-15
N219379-001	12357597	2041-02-17	U-4130		2025-07-16
N219379-001	11839595	2043-03-16	U-4130		2025-02-14
N219379-001	11883375	2043-03-16	U-4130		2025-02-14
N219379-001	12220390	2043-03-16	U-4130		2025-02-14
N219379-001	12257215	2043-03-16	U-4130		2025-04-03
N219379-001	12324791	2043-03-16	U-4591		2025-06-16
N219379-001	11806322	2043-04-09	U-4130		2025-02-14
N219379-001	12661330	2044-02-05	U-4130		2026-07-02
N219379-001	12029711	2044-03-15	U-4130	Drug product	2025-02-14
N219379-001	12390430	2044-10-10	U-4130		2025-08-20
N219379-002	11066358	2041-02-17		Drug substance, Drug product	2026-08-27
N219379-002	11084780	2041-02-17		Drug substance	2026-08-27
N219379-002	11453641	2041-02-17	U-4130		2026-08-27
N219379-002	11571402	2041-02-17		Drug product	2026-08-27
N219379-002	11806321	2041-02-17	U-4130		2026-08-27
N219379-002	11819487	2041-02-17	U-4590		2026-08-27
N219379-002	12037306	2041-02-17	U-4130		2026-08-27
N219379-002	12263146	2041-02-17	U-4130		2026-08-27
N219379-002	12295925	2041-02-17	U-4590		2026-08-27
N219379-002	12357597	2041-02-17	U-4130		2026-08-27
N219379-002	11883375	2043-03-16	U-4130		2026-08-27
N219379-002	12220390	2043-03-16	U-4130		2026-08-27
N219379-002	12257215	2043-03-16	U-4130		2026-08-27
N219379-002	12324791	2043-03-16	U-4591		2026-08-27
N219379-002	12661330	2044-02-05	U-4130		2026-08-27
N219379-002	12029711	2044-03-15	U-4130	Drug product	2026-08-27
N219379-002	12390430	2044-10-10	U-4130		2026-08-27
N219379-003	11066358	2041-02-17		Drug substance, Drug product	2026-08-27
N219379-003	11084780	2041-02-17		Drug substance	2026-08-27
N219379-003	11453641	2041-02-17	U-4130		2026-08-27
N219379-003	11571402	2041-02-17		Drug product	2026-08-27
N219379-003	11806321	2041-02-17	U-4130		2026-08-27
N219379-003	11819487	2041-02-17	U-4590		2026-08-27
N219379-003	12037306	2041-02-17	U-4130		2026-08-27
N219379-003	12263146	2041-02-17	U-4130		2026-08-27
N219379-003	12295925	2041-02-17	U-4590		2026-08-27
N219379-003	12357597	2041-02-17	U-4130		2026-08-27
N219379-003	12220390	2043-03-16	U-4130		2026-08-27
N219379-003	12324791	2043-03-16	U-4591		2026-08-27
N219379-003	12661330	2044-02-05	U-4130		2026-08-27
N219379-003	12029711	2044-03-15	U-4130	Drug product	2026-08-27
N219379-003	12390430	2044-10-10	U-4130		2026-08-27

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N219379-001	NCE	2030-02-11
N219379-001	ODE-488	2032-02-11
N219379-002	NCE	2030-02-11
N219379-002	ODE*	2032-02-11
N219379-003	NCE	2030-02-11
N219379-003	ODE*	2032-02-11

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
2026-09-14 22:38:34	2026-08	N219379-001	GOMEKLI	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	GOMEKLI	3MG	TABLET, FOR SUSPENSION / ORAL	RLD	2026-07-28	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-003	GOMEKLI	4MG	TABLET, FOR SUSPENSION / ORAL	RLD	2026-07-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219379-001	GOMEKLI	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219379-002	GOMEKLI	3MG	TABLET, FOR SUSPENSION / ORAL	RLD	2026-07-28	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219379-003	GOMEKLI	4MG	TABLET, FOR SUSPENSION / ORAL	RLD	2026-07-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219379-001	GOMEKLI	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	GOMEKLI	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219379-001	GOMEKLI	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219379-001	GOMEKLI	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219379-001	GOMEKLI	1MG	TABLET, FOR SUSPENSION / ORAL	RLD, RS	2025-02-11	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 5 · 168 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	N219379-001	11066358	2041-02-17		Drug substance	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11084780	2041-02-17		Drug substance	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11453641	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11571402	2041-02-17		Drug product	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11806321	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11819487	2041-02-17	U-4590		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12011424	2041-02-17	U-4595		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12037306	2041-02-17	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12090128	2041-02-17	U-4130	Drug product	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12263146	2041-02-17	U-4130		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12295925	2041-02-17	U-4590		2025-05-15	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12357597	2041-02-17	U-4130		2025-07-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11839595	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11883375	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12220390	2043-03-16	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12257215	2043-03-16	U-4130		2025-04-03	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12324791	2043-03-16	U-4591		2025-06-16	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	11806322	2043-04-09	U-4130		2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12661330	2044-02-05	U-4130		2026-07-02	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12029711	2044-03-15	U-4130	Drug product	2025-02-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	12390430	2044-10-10	U-4130		2025-08-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	11066358	2041-02-17		Drug substance, Drug product	2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	11084780	2041-02-17		Drug substance	2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	11453641	2041-02-17	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	11571402	2041-02-17		Drug product	2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	11806321	2041-02-17	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	11819487	2041-02-17	U-4590		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12037306	2041-02-17	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12263146	2041-02-17	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12295925	2041-02-17	U-4590		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12357597	2041-02-17	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	11883375	2043-03-16	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12220390	2043-03-16	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12257215	2043-03-16	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12324791	2043-03-16	U-4591		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12661330	2044-02-05	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12029711	2044-03-15	U-4130	Drug product	2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	12390430	2044-10-10	U-4130		2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-003	11066358	2041-02-17		Drug substance, Drug product	2026-08-27	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-003	11084780	2041-02-17		Drug substance	2026-08-27	`84e616aacf4f…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N219379-001	NCE	2030-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-001	ODE-488	2032-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	NCE	2030-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-002	ODE*	2032-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-003	NCE	2030-02-11	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N219379-003	ODE*	2032-02-11	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N219379-001	NCE	2030-02-11	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N219379-001	ODE-488	2032-02-11	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N219379-001	NCE	2030-02-11	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	ODE-488	2032-02-11	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	NCE	2030-02-11	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	ODE-488	2032-02-11	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N219379-001	NCE	2030-02-11	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N219379-001	ODE-488	2032-02-11	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N219379-001	NCE	2030-02-11	`fd3edfee7708…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219379-001	NCE	2030-02-11	`a50c72e98297…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N219379-001	ODE-488	2032-02-11	`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: Gomekli
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MIRDAMETINIB	1 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5c1d6cbc-e335-486e-b41c-3bb098c33b97	Product name	1	20251120
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82448-134-42	Gomekli	42 in 1 BOTTLE	TABLET, FOR SUSPENSION	42		6
82448-134-84	Gomekli	84 in 1 BOTTLE	TABLET, FOR SUSPENSION	84		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82448-134-42	EA - Each	82448-134	82de1642-1481-41e8-8ad6-d104706d5b68	1	2025-03-04
82448-134-84	EA - Each	82448-134	aca534d1-bf86-4aa5-b33a-230f70b846a8	1	2025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82448-134	GOMEKLI (MIRDAMETINIB) CAPSULE GOMEKLI (MIRDAMETINIB) TABLET, FOR SUSPENSION [SPRINGWORKS THERAPEUTICS, INC.]	4	Current NDC, 2 package rows	20250328_4c41bf90-5fa7-4935-a95c-e047ea6bbf8e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2705623	GOMEKLI 1 MG Oral Capsule	PSN	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705635	GOMEKLI 1 MG Tablet for Oral Suspension	PSN	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705628	GOMEKLI 2 MG Oral Capsule	PSN	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705617	mirdametinib 1 MG Oral Capsule	PSN	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705632	mirdametinib 1 MG Tablet for Oral Suspension	PSN	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705626	mirdametinib 2 MG Oral Capsule	PSN	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705623	mirdametinib 1 MG Oral Capsule [Gomekli]	SBD	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705635	mirdametinib 1 MG Tablet for Oral Suspension [Gomekli]	SBD	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705628	mirdametinib 2 MG Oral Capsule [Gomekli]	SBD	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705617	mirdametinib 1 MG Oral Capsule	SCD	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705632	mirdametinib 1 MG Tablet for Oral Suspension	SCD	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705626	mirdametinib 2 MG Oral Capsule	SCD	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705623	Gomekli 1 MG Oral Capsule	SY	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705635	Gomekli 1 MG Tablet for Oral Suspension	SY	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6
2705628	Gomekli 2 MG Oral Capsule	SY	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	6

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82448-134-84	82448013484	84 TABLET, FOR SUSPENSION in 1 BOTTLE (82448-134-84)	2025-02-11	No	No	Current