TARCEVA

Product NDC: 50242-063
11-digit product format: 502420063
Labeler code: 50242
Product ID: 50242-063_5c1bf1f1-3ef7-4411-9305-b4f4080b769a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: erlotinib hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Genentech, Inc.
Application: NDA021743
Marketing category: NDA
Marketing start: 2005-04-30
Marketing end: 0000-00-00
Substance: ERLOTINIB HYDROCHLORIDE
Active strength: 100 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50242-063		D	Discontinued by firm		2026-08-11
excluded package	package	50242-063	50242-063-01	D	Discontinued by firm		2026-08-11

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021743-001	TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18
N021743-002	TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18
N021743-003	TARCEVA	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18

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 4 · 123 observed 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	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021743-001	TARCEVA	EQ 25MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021743-002	TARCEVA	EQ 100MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021743-003	TARCEVA	EQ 150MG BASE Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET / ORAL	RLD	2004-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021743-002	TARCEVA	EQ 100MG BASE	TABLET / ORAL	RLD	2004-11-18	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021743-003	TARCEVA	EQ 150MG BASE	TABLET / ORAL	RLD	2004-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021743-002	TARCEVA	EQ 100MG BASE	TABLET / ORAL	RLD	2004-11-18	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021743-003	TARCEVA	EQ 150MG BASE	TABLET / ORAL	RLD	2004-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021743-002	TARCEVA	EQ 100MG BASE	TABLET / ORAL	RLD	2004-11-18	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021743-003	TARCEVA	EQ 150MG BASE	TABLET / ORAL	RLD	2004-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021743-001	TARCEVA	EQ 25MG BASE	TABLET / ORAL	RLD	2004-11-18	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 57 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021743-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021743-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021743-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021743-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021743-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021743-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021743-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021743-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021743-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021743-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021743-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021743-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021743-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021743-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021743-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021743-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N021743-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021743-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021743-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N021743-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021743-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021743-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N021743-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021743-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021743-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021743-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	AB	1	`ea99ee380514…`
2023-05-13 08:27 UTC	2023-05	N021743-001	AB	1	`053a50430f4f…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 204 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021743-001	5747498*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	RE41065*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-875	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-1403	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-659	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221	2020-11-09	U-1046	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613	2020-11-09	U-1045		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613	2020-11-09	U-659		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613	2020-11-09	U-1403		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	6900221*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	7087613*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	5747498*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	RE41065*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-659	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-1046	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-1403	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221	2020-11-09	U-875	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613	2020-11-09	U-659		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613	2020-11-09	U-1403		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613	2020-11-09	U-1045		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	6900221*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	7087613*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	5747498*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	RE41065*PED	2019-05-08		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-875	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-1403	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-1046	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221	2020-11-09	U-659	Drug substance, Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613	2020-11-09	U-1403		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613	2020-11-09	U-1045		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613	2020-11-09	U-659		`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	6900221*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	7087613*PED	2021-05-09		Pediatric extension	`74a2ff9319b5…`
2021-12-28 21:50 UTC	2021-12	N021743-001	6900221*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-001	7087613*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-002	6900221*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-002	7087613*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-003	6900221*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021743-003	7087613*PED	2021-05-09		Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021743-001	6900221*PED	2021-05-09		Pediatric extension	`87673890dc5c…`

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	N021743-001	D-164	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	M-181	2019-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-001	M-190	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	D-164	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	M-181	2019-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-002	M-190	2019-10-18	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	D-164	2019-05-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	M-181	2019-06-01	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021743-003	M-190	2019-10-18	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021743-001	D-164	2019-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-001	M-181	2019-06-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-001	M-190	2019-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	D-164	2019-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	M-181	2019-06-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-002	M-190	2019-10-18	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	D-164	2019-05-20	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	M-181	2019-06-01	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	N021743-003	M-190	2019-10-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021743-001	D-164	2019-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-001	M-181	2019-06-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-001	M-190	2019-10-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	D-164	2019-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	M-181	2019-06-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-002	M-190	2019-10-18	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	D-164	2019-05-20	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	M-181	2019-06-01	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	N021743-003	M-190	2019-10-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021743-001	D-164	2019-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-001	M-181	2019-06-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-001	M-190	2019-10-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	D-164	2019-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	M-181	2019-06-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-002	M-190	2019-10-18	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	D-164	2019-05-20	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	M-181	2019-06-01	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	N021743-003	M-190	2019-10-18	`ea99ee380514…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bd23d1a5-e4ff-4f92-da3b-5034c014ad1a	Product name	8	20250331

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50242-063-01	EA - Each	50242-063	163253e7-57af-4342-b677-7eab5bbe644a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
erlotinib hydrochloride	ACTIVE INGREDIENT	DA87705X9K	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [GENENTECH, INC.]	12
ERLOTINIB	ACTIVE MOIETY	J4T82NDH7E	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [GENENTECH, INC.]	12
ERLOTINIB HYDROCHLORIDE	ACTIVE INGREDIENT	DA87705X9K	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
ERLOTINIB	ACTIVE MOIETY	J4T82NDH7E	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50242-063	TARCEVA (ERLOTINIB HYDROCHLORIDE) TABLET [GENENTECH, INC.]	16	Legacy NDC	20181220_57bccb29-1c47-4c64-ab6a-77960a91cc20.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DA87705X9K	ERLOTINIB HYDROCHLORIDE	183319-69-9	ERLOTINIB HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
603203	erlotinib 100 MG Oral Tablet	PSN	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603206	erlotinib 150 MG Oral Tablet	PSN	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603208	erlotinib 25 MG Oral Tablet	PSN	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088251	Tarceva 100 MG Oral Tablet	PSN	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088253	Tarceva 150 MG Oral Tablet	PSN	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088255	Tarceva 25 MG Oral Tablet	PSN	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088251	erlotinib 100 MG Oral Tablet [Tarceva]	SBD	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088253	erlotinib 150 MG Oral Tablet [Tarceva]	SBD	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088255	erlotinib 25 MG Oral Tablet [Tarceva]	SBD	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603203	erlotinib 100 MG Oral Tablet	SCD	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603206	erlotinib 150 MG Oral Tablet	SCD	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603208	erlotinib 25 MG Oral Tablet	SCD	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603208	erlotinib (as erlotinib hydrochloride) 25 MG Oral Tablet	SY	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603203	erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral Tablet	SY	5783976b-0862-44e5-9b19-0f41d236d5c3	1
603206	erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral Tablet	SY	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088251	Tarceva 100 MG Oral Tablet	SY	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088253	Tarceva 150 MG Oral Tablet	SY	5783976b-0862-44e5-9b19-0f41d236d5c3	1
1088255	Tarceva 25 MG Oral Tablet	SY	5783976b-0862-44e5-9b19-0f41d236d5c3	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50242-063-01	50242006301	30 TABLET in 1 BOTTLE (50242-063-01)	30 tablet	2005-04-30	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TARCEVA	Genentech, Inc.	2018-12-12	HUMAN PRESCRIPTION DRUG LABEL	16
Tarceva	Physicians Total Care, Inc.	2012-01-05	HUMAN PRESCRIPTION DRUG LABEL	1