Erlotinib

Product NDC: 63304-135
11-digit product format: 633040135
Labeler code: 63304
Product ID: 63304-135_c160713b-c06f-49b4-80ea-fc1afb030b81
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erlotinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Sun Pharmaceutical Industries, Inc.
Application: ANDA210300
Marketing category: ANDA
Marketing start: 2019-11-05
Marketing end: 0000-00-00
Substance: ERLOTINIB
Active strength: 150 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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	63304-135		D	Discontinued by firm	2026-10-27
excluded package	package	63304-135	63304-135-11	D	Discontinued by firm	2026-10-27
excluded package	package	63304-135	63304-135-30	D	Discontinued by firm	2026-10-27

Source provenance: Browse the complete Orange Book source catalog · source snapshot 44.

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	Approval date
A210300-001	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2019-11-05
A210300-002	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2019-11-05
A210300-003	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2019-11-05

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 · 126 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 100 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210300-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210300-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210300-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210300-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210300-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210300-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210300-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210300-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210300-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210300-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210300-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210300-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210300-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210300-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210300-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A210300-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210300-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210300-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210300-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210300-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210300-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210300-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210300-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210300-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210300-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210300-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210300-002	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A210300-003	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210300-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210300-002	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210300-003	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210300-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210300-002	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A210300-003	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210300-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210300-002	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A210300-003	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210300-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210300-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A210300-003	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
63304-135-11	Erlotinib	3 in 1 CARTON	TABLET, FILM COATED	3	3
63304-135-30	Erlotinib	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
63304-135-31	Erlotinib	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63304-135-30	EA - Each	63304-135	d2a71666-bf7e-4cb7-bd59-563a16cdeecf	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-135	ERLOTINIB TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	3	Legacy NDC, 3 package rows	20191106_e36fa076-e23b-437f-bbd2-0433ce333175.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
J4T82NDH7E	ERLOTINIB	183321-74-6	ERLOTINIB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
603203	erlotinib 100 MG Oral Tablet	PSN	e36fa076-e23b-437f-bbd2-0433ce333175	3
603206	erlotinib 150 MG Oral Tablet	PSN	e36fa076-e23b-437f-bbd2-0433ce333175	3
603208	erlotinib 25 MG Oral Tablet	PSN	e36fa076-e23b-437f-bbd2-0433ce333175	3
603203	erlotinib 100 MG Oral Tablet	SCD	e36fa076-e23b-437f-bbd2-0433ce333175	3
603206	erlotinib 150 MG Oral Tablet	SCD	e36fa076-e23b-437f-bbd2-0433ce333175	3
603208	erlotinib 25 MG Oral Tablet	SCD	e36fa076-e23b-437f-bbd2-0433ce333175	3
603208	erlotinib (as erlotinib hydrochloride) 25 MG Oral Tablet	SY	e36fa076-e23b-437f-bbd2-0433ce333175	3
603203	erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral Tablet	SY	e36fa076-e23b-437f-bbd2-0433ce333175	3
603206	erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral Tablet	SY	e36fa076-e23b-437f-bbd2-0433ce333175	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63304-135-11	63304013511	3 BLISTER PACK in 1 CARTON (63304-135-11) > 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-135-31)	3 blister pack	2019-11-05	0000-00-00	No	No	Current
63304-135-30	63304013530	30 TABLET, FILM COATED in 1 BOTTLE (63304-135-30)		2019-11-05	0000-00-00	No	No	Current
63304-135-31	63304013531	10 in 1 BLISTER PACK						Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erlotinib	Sun Pharmaceutical Industries, Inc. \| Sun Pharmaceutical Industries Limited	2019-11-06	HUMAN PRESCRIPTION DRUG LABEL	3