Gomekli

Product NDC: 82448-134
Requested package NDC: 82448-134-84
11-digit product format: 824480134
Labeler code: 82448
Product ID: 82448-134_849abb0f-1b19-4b4f-a3fe-113869a59653
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N219379-001	GOMEKLI	MIRDAMETINIB	1MG	TABLET, FOR SUSPENSION / ORAL		RLD, RS	2025-02-11

Orange Book patents#

Current patent rows page 1 of 1 · 21 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-4130		2025-02-14
N219379-001	12011424	2041-02-17	U-4130		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-4130		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-4130		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

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 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

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
2026-02-19 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 3 · 94 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N219379-001	11066358	2041-02-17		Drug substance	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11084780	2041-02-17		Drug substance	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11453641	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11571402	2041-02-17		Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11806321	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11819487	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12011424	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12037306	2041-02-17	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12090128	2041-02-17	U-4130	Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12263146	2041-02-17	U-4130		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12295925	2041-02-17	U-4130		2025-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12357597	2041-02-17	U-4130		2025-07-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11839595	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11883375	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12220390	2043-03-16	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12257215	2043-03-16	U-4130		2025-04-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12324791	2043-03-16	U-4130		2025-06-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	11806322	2043-04-09	U-4130		2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12029711	2044-03-15	U-4130	Drug product	2025-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N219379-001	12390430	2044-10-10	U-4130		2025-08-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11066358	2041-02-17		Drug substance	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11084780	2041-02-17		Drug substance	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11453641	2041-02-17	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11571402	2041-02-17		Drug product	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11806321	2041-02-17	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11819487	2041-02-17	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12011424	2041-02-17	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12037306	2041-02-17	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12090128	2041-02-17	U-4130	Drug product	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12263146	2041-02-17	U-4130		2025-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12295925	2041-02-17	U-4130		2025-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12357597	2041-02-17	U-4130		2025-07-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11839595	2043-03-16	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11883375	2043-03-16	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12220390	2043-03-16	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12257215	2043-03-16	U-4130		2025-04-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12324791	2043-03-16	U-4130		2025-06-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	11806322	2043-04-09	U-4130		2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12029711	2044-03-15	U-4130	Drug product	2025-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N219379-001	12390430	2044-10-10	U-4130		2025-08-20	`31067a03dcf5…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
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…`

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
86K0J5AK6M	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2705617	Internal RxNorm lookup
2705623	Internal RxNorm lookup
2705626	Internal RxNorm lookup
2705628	Internal RxNorm lookup
2705632	Internal RxNorm lookup
2705635	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
4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	Available on FDA.report

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

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
Gomekli	MIRDAMETINIB	SpringWorks Therapeutics, Inc.	4c41bf90-5fa7-4935-a95c-e047ea6bbf8e	2026-07-10	Warnings, Adverse reactions	Exact identifier application applno (NDA): 219379 application number: NDA219379 ndc (package): 82448-134-84 ndc (product): 82448-134 ndc11 (package): 82448013484

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