Erlotinib

Product NDC: 63304-095
11-digit product format: 633040095
Labeler code: 63304
Product ID: 63304-095_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
Substance: ERLOTINIB
Active strength: 25 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC], Protein Kinase 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 · 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 3 · 117 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
2026-02-19 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…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210300-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210300-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	AB	2019-11-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210300-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	AB	2019-11-05	`8072bd15b7f6…`

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…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERLOTINIB	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
J4T82NDH7E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
603203	Internal RxNorm lookup
603206	Internal RxNorm lookup
603208	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
e36fa076-e23b-437f-bbd2-0433ce333175	Available on FDA.report

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
63304-095-11	Erlotinib	3 in 1 CARTON	TABLET, FILM COATED	3	3
63304-095-30	Erlotinib	30 in 1 BOTTLE	TABLET, FILM COATED	30	3
63304-095-31	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
63304-095-30	EA - Each	63304-095	78ccd5e1-f88d-4d21-9f51-ac134c5e550d	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63304-095	ERLOTINIB TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.]	3	Current NDC, Legacy NDC, 3 package rows	20191106_e36fa076-e23b-437f-bbd2-0433ce333175.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
Erlotinib	ERLOTINIB	Sun Pharmaceutical Industries, Inc.	e36fa076-e23b-437f-bbd2-0433ce333175	2019-11-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210300 application number: ANDA210300 ndc (product): 63304-095

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
63304-095-11	63304009511	3 BLISTER PACK in 1 CARTON (63304-095-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-095-31)	3 blister pack	2019-11-05	0000-00-00	No	No	Current
63304-095-30	63304009530	30 TABLET, FILM COATED in 1 BOTTLE (63304-095-30)		2019-11-05	0000-00-00	No	No	Current
63304-095-31	63304009531	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