TEPMETKO

Product NDC: 44087-5000
11-digit product format: 440875000
Labeler code: 44087
Product ID: 44087-5000_d922de79-b0f0-4ed2-b551-c7a86ed72d7d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Tepotinib Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: EMD Serono, Inc.
Application: NDA214096
Marketing category: NDA
Marketing start: 2021-02-03
Substance: TEPOTINIB HYDROCHLORIDE
Active strength: 225 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Mesenchymal Epithelial Transition Inhibitors [MoA], P-Glycoprotein Inhibitors [MoA]
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 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
N214096-001	TEPMETKO	TEPOTINIB HYDROCHLORIDE	EQ 225MG BASE	TABLET / ORAL		RLD, RS	2021-02-03

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
N214096-001	9284300	2028-04-29		Drug product	2021-03-03
N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03
N214096-001	8658643	2028-07-04	U-3077		2021-03-03
N214096-001	9062029	2028-07-04		Drug product	2021-03-03
N214096-001	9403799	2028-07-04	U-3077		2021-03-03
N214096-001	8927540	2028-07-21	U-3078		2021-03-03
N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03
N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 2 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N214096-001	NCE	2026-02-03
N214096-001	ODE-325	2028-02-03

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	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`87673890dc5c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N214096-001	TEPMETKO	EQ 225MG BASE	TABLET / ORAL	RLD, RS	2021-02-03	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 272 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	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	9284300	2028-04-29		Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8921357	2028-05-30		Drug substance, Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8658643	2028-07-04	U-3077		2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	9062029	2028-07-04		Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	9403799	2028-07-04	U-3077		2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8927540	2028-07-21	U-3078		2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8329692	2029-10-30		Drug substance, Drug product	2021-03-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	8580781	2030-03-19		Drug substance, Drug product	2021-03-03	`b8a1b40f171c…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 68 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N214096-001	NCE	2026-02-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N214096-001	ODE-325	2028-02-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	NCE	2026-02-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N214096-001	ODE-325	2028-02-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N214096-001	NCE	2026-02-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N214096-001	ODE-325	2028-02-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	NCE	2026-02-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N214096-001	ODE-325	2028-02-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	NCE	2026-02-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N214096-001	ODE-325	2028-02-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214096-001	NCE	2026-02-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N214096-001	ODE-325	2028-02-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214096-001	NCE	2026-02-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N214096-001	ODE-325	2028-02-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214096-001	NCE	2026-02-03	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N214096-001	ODE-325	2028-02-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214096-001	NCE	2026-02-03	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N214096-001	ODE-325	2028-02-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N214096-001	NCE	2026-02-03	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N214096-001	ODE-325	2028-02-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214096-001	NCE	2026-02-03	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N214096-001	ODE-325	2028-02-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214096-001	NCE	2026-02-03	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N214096-001	ODE-325	2028-02-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214096-001	NCE	2026-02-03	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N214096-001	ODE-325	2028-02-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N214096-001	NCE	2026-02-03	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N214096-001	ODE-325	2028-02-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214096-001	NCE	2026-02-03	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N214096-001	ODE-325	2028-02-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N214096-001	NCE	2026-02-03	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N214096-001	ODE-325	2028-02-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N214096-001	NCE	2026-02-03	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N214096-001	ODE-325	2028-02-03	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N214096-001	NCE	2026-02-03	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N214096-001	ODE-325	2028-02-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N214096-001	NCE	2026-02-03	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N214096-001	ODE-325	2028-02-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214096-001	NCE	2026-02-03	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N214096-001	ODE-325	2028-02-03	`87673890dc5c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
TEPOTINIB HYDROCHLORIDE	225 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
VY5YX2TQ1F	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2477266	Internal RxNorm lookup
2477272	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
80a0f1b9-071a-47f5-9e67-32d638a669dc	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4545044d-7660-4513-8a33-dad91ffdcfbe	Product name	1	20210625

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
44087-5000-3	2021-09-27	These highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021
44087-5000-6	2021-09-27	These highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021
44087-5000-3	2021-07-23	These highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021
44087-5000-6	2021-07-23	These highlights do not include all the information needed to use TEPMETKO safely and effectively. See full prescribing information for TEPMETKO. TEPMETKO ® (tepotinib) tablets, for oral use Initial U.S. Approval: 2021

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
44087-5000-3	TEPMETKO	3 in 1 CARTON	TABLET	3	8
44087-5000-3	TEPMETKO	10 in 1 BLISTER PACK	TABLET	10	8
44087-5000-6	TEPMETKO	10 in 1 BLISTER PACK	TABLET	10	8
44087-5000-6	TEPMETKO	6 in 1 CARTON	TABLET	6	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
44087-5000-3	EA - Each	44087-5000	fc27d82d-e35d-4244-9616-f1d985af170b	1	2021-03-02
44087-5000-6	EA - Each	44087-5000	1e11ed05-4e05-4d00-9021-6e5d0b21e363	1	2021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
44087-5000	TEPMETKO (TEPOTINIB HYDROCHLORIDE) TABLET [EMD SERONO, INC.]	8	Current NDC, Legacy NDC, 4 package rows	20250422_80a0f1b9-071a-47f5-9e67-32d638a669dc.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
TEPMETKO	TEPOTINIB HYDROCHLORIDE	EMD Serono, Inc.	80a0f1b9-071a-47f5-9e67-32d638a669dc	2025-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 214096 application number: NDA214096 ndc (product): 44087-5000

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2477272	TEPMETKO 225 MG Oral Tablet	PSN	80a0f1b9-071a-47f5-9e67-32d638a669dc	8
2477266	tepotinib 225 MG Oral Tablet	PSN	80a0f1b9-071a-47f5-9e67-32d638a669dc	8
2477272	tepotinib 225 MG Oral Tablet [Tepmetko]	SBD	80a0f1b9-071a-47f5-9e67-32d638a669dc	8
2477266	tepotinib 225 MG Oral Tablet	SCD	80a0f1b9-071a-47f5-9e67-32d638a669dc	8
2477272	Tepmetko 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral Tablet	SY	80a0f1b9-071a-47f5-9e67-32d638a669dc	8
2477272	Tepmetko 225 MG Oral Tablet	SY	80a0f1b9-071a-47f5-9e67-32d638a669dc	8
2477266	tepotinib 225 MG (equivalent to tepotinib HCl hydrate 250 MG) Oral Tablet	SY	80a0f1b9-071a-47f5-9e67-32d638a669dc	8

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
44087-5000-3	44087500003	3 BLISTER PACK in 1 CARTON (44087-5000-3) / 10 TABLET in 1 BLISTER PACK	3 blister pack	2021-02-03	0000-00-00	No	No	Current
44087-5000-6	44087500006	6 BLISTER PACK in 1 CARTON (44087-5000-6) / 10 TABLET in 1 BLISTER PACK	6 blister pack	2021-02-03	0000-00-00	No	No	Current