Erlotinib

Product NDC: 51991-892
11-digit product format: 519910892
Labeler code: 51991
Product ID: 51991-892_b2190c5f-7d87-4744-bcee-41bc2ee59b74
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erlotinib Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA208488
Marketing category: ANDA
Marketing start: 2019-11-05
Marketing end: 0000-00-00
Substance: ERLOTINIB HYDROCHLORIDE
Active strength: 150 mg/1
Pharmacologic classes: Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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	51991-892		D	Discontinued by firm		2026-10-16
excluded package	package	51991-892	51991-892-33	D	Discontinued by firm		2026-10-16

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	51991-892-33	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	51991-892-33	`f5e01cc5f278…`	`a2eaf40c39c3…`

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
A208488-001	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2019-11-05
A208488-002	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2019-11-05
A208488-003	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	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL		2019-11-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208488-002	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	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208488-002	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	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208488-002	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	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208488-002	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	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208488-002	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	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208488-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	AB	2019-11-05	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A208488-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL		2019-11-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208488-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL		2019-11-05	`79d66fd596c7…`

Observed Orange Book normalized TE history#

Normalized TE history page 2 of 3 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2020-12-22 03:56 UTC	2020-12	A208488-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208488-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A208488-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208488-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208488-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A208488-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208488-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208488-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A208488-003	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208488-001	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208488-002	AB	1	`6a51e52b5d6a…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208488-003	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208488-001	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208488-002	AB	1	`1c564ffb4f44…`
2024-02-18 07:12 UTC	2024-02	A208488-003	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208488-001	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208488-002	AB	1	`ea1830bbd6c7…`
2023-12-20 04:57 UTC	2023-12	A208488-003	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208488-001	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208488-002	AB	1	`a72a2bbeb626…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208488-003	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208488-001	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208488-002	AB	1	`9b2671bbb829…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208488-003	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208488-001	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208488-002	AB	1	`a67488948f0b…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208488-003	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208488-001	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208488-002	AB	1	`3f0d92c62455…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208488-003	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208488-001	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208488-002	AB	1	`053a50430f4f…`
2023-05-13 08:27 UTC	2023-05	A208488-003	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208488-001	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208488-002	AB	1	`3bdfa0b2c4d7…`
2023-01-26 05:58 UTC	2023-01	A208488-003	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208488-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208488-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208488-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208488-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-892-33	EA - Each	51991-892	f3ca8806-ee63-46b4-8156-07f053812c32	1	2019-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-892	ERLOTINIB (ERLOTINIB HYDROCHLORIDE) TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	3	Legacy NDC	20230202_3527fba1-a7d2-4c1c-99dc-ba53cec84994.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-892-33	51991089233	30 TABLET, FILM COATED in 1 BOTTLE (51991-892-33)	2019-11-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erlotinib	Breckenridge Pharmaceutical, Inc. \| Natco Pharma Limited	2023-01-24	HUMAN PRESCRIPTION DRUG LABEL	3