TYKERB

Product NDC: 0078-0671
11-digit product format: 000780671
Labeler code: 0078
Product ID: 0078-0671_940eccaf-92b4-4562-8579-24a53c1bc48d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: lapatinib
Dosage form: TABLET
Route: ORAL
Labeler: Novartis Pharmaceuticals Corporation
Application: NDA022059
Marketing category: NDA
Marketing start: 2016-08-03
Substance: LAPATINIB DITOSYLATE
Active strength: 250 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Protein Kinase 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 42.

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
N022059-001	TYKERB	LAPATINIB DITOSYLATE	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N022059-001	AB

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03

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.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL		RLD, RS	2007-03-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL		RLD, RS	2007-03-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL		RLD, RS	2007-03-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL		RLD, RS	2007-03-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022059-001	TYKERB	EQ 250MG BASE	TABLET / ORAL	AB	RLD, RS	2007-03-13	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N022059-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022059-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022059-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022059-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022059-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022059-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022059-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022059-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022059-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022059-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022059-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022059-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022059-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022059-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022059-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022059-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022059-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022059-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022059-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022059-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022059-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022059-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022059-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022059-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022059-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022059-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022059-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022059-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022059-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022059-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022059-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022059-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022059-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022059-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022059-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022059-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022059-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022059-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 2 · 75 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022059-001	6727256	2019-01-08	U-800	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022059-001	6727256	2019-01-08	U-1429	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022059-001	8513262	2019-01-08		Drug substance, Drug product	2013-09-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022059-001	6713485	2020-09-29	U-800	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022059-001	6713485	2020-09-29	U-1429	Drug substance, Drug product		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022059-001	7157466	2021-11-19		Drug substance, Drug product	2013-10-24	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022059-001	7157466	2021-11-19		Drug substance, Drug product	2013-10-24	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022059-001	7157466	2021-11-19		Drug substance, Drug product	2013-10-24	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022059-001	7157466	2021-11-19		Drug substance, Drug product	2013-10-24	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022059-001	6713485	2020-09-29	U-1429	Drug substance, Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022059-001	6713485	2020-09-29	U-800	Drug substance, Drug product		`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022059-001	7157466	2021-11-19		Drug substance, Drug product	2013-10-24	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022059-001	6713485	2020-09-29	U-800	Drug substance, Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022059-001	6713485	2020-09-29	U-1429	Drug substance, Drug product		`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022059-001	7157466	2021-11-19		Drug substance, Drug product	2013-10-24	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N022059-001	8821927	2029-09-18		Drug substance, Drug product	2014-10-03	`c0c555d07b60…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N022059-001	M-235	2021-12-06	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N022059-001	M-235	2021-12-06	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022059-001	M-235	2021-12-06	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022059-001	M-235	2021-12-06	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022059-001	M-235	2021-12-06	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022059-001	M-235	2021-12-06	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022059-001	M-235	2021-12-06	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022059-001	M-235	2021-12-06	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022059-001	M-235	2021-12-06	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: TYKERB
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LAPATINIB DITOSYLATE	250 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
G873GX646R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
672149	Internal RxNorm lookup
672152	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
eee37f88-ec6a-4c30-b8aa-e2c71f93088c	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5e802855-bae9-a3e9-f938-a726f169ef05	Product name	3	20250317

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0078-0671-19	2023-08-01	C162847	48780-1	0191ceaa-6bde-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use TYKERB safely and effectively. See full prescribing information for TYKERB. TYKERB ® (lapatinib) tablets, for oral use Initial U.S. Approval: 2007
0078-0671-19	2023-07-28	C162847	48780-1	0191ceaa-6bde-198a-e063-dbdaa90aec3e	These highlights do not include all the information needed to use TYKERB safely and effectively. See full prescribing information for TYKERB. TYKERB ® (lapatinib) tablets, for oral use Initial U.S. Approval: 2007

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0078-0671-19	TYKERB	150 in 1 BOTTLE	TABLET	150		14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0078-0671-19	EA - Each	0078-0671	d8565b5c-fe4d-4404-91e1-eaeb86081571	1	2016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0078-0671	TYKERB (LAPATINIB) TABLET [NOVARTIS PHARMACEUTICALS CORPORATION]	12	Current NDC, Legacy NDC, 1 package rows	20250112_eee37f88-ec6a-4c30-b8aa-e2c71f93088c.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
TYKERB	LAPATINIB	Novartis Pharmaceuticals Corporation	eee37f88-ec6a-4c30-b8aa-e2c71f93088c	2026-01-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 022059 application number: NDA022059 ndc (product): 0078-0671

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G873GX646R	LAPATINIB DITOSYLATE	388082-78-8	LAPATINIB DITOSYLATE
0VUA21238F	LAPATINIB	231277-92-2	lapatinib

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
672149	lapatinib 250 MG Oral Tablet	PSN	eee37f88-ec6a-4c30-b8aa-e2c71f93088c	14
672152	Tykerb 250 MG Oral Tablet	PSN	eee37f88-ec6a-4c30-b8aa-e2c71f93088c	14
672152	lapatinib 250 MG Oral Tablet [Tykerb]	SBD	eee37f88-ec6a-4c30-b8aa-e2c71f93088c	14
672149	lapatinib 250 MG Oral Tablet	SCD	eee37f88-ec6a-4c30-b8aa-e2c71f93088c	14
672149	lapatinib 250 MG (as lapatinib ditosylate 398 MG) Oral Tablet	SY	eee37f88-ec6a-4c30-b8aa-e2c71f93088c	14
672152	Tykerb 250 MG Oral Tablet	SY	eee37f88-ec6a-4c30-b8aa-e2c71f93088c	14

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0078-0671-19	00078067119	150 TABLET in 1 BOTTLE (0078-0671-19)	150 tablet	2016-08-03	0000-00-00	No	No	Current