Erlotinib

Product NDC: 59651-530
11-digit product format: 596510530
Labeler code: 59651
Product ID: 59651-530_3ecafc1e-979a-4aff-a276-18fc0b110491
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Erlotinib
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aurobindo Pharma Limited
Application: ANDA216342
Marketing category: ANDA
Marketing start: 2022-06-22
Substance: ERLOTINIB HYDROCHLORIDE
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
A216342-001	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22
A216342-002	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22
A216342-003	ERLOTINIB HYDROCHLORIDE	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22

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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216342-002	ERLOTINIB HYDROCHLORIDE	EQ 100MG BASE	TABLET / ORAL	2022-06-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A216342-003	ERLOTINIB HYDROCHLORIDE	EQ 150MG BASE	TABLET / ORAL	2022-06-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A216342-001	ERLOTINIB HYDROCHLORIDE	EQ 25MG BASE	TABLET / ORAL	2022-06-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216342-001	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216342-002	AB	1	`3a93d1ddd44b…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A216342-003	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A216342-001	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A216342-002	AB	1	`f41ea6bd6efb…`
2022-10-28 04:53 UTC	2022-10	A216342-003	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A216342-001	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A216342-002	AB	1	`e64feba35796…`
2022-09-29 23:25 UTC	2022-09	A216342-003	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216342-001	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216342-002	AB	1	`cb3db0bc1861…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A216342-003	AB	1	`cb3db0bc1861…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ERLOTINIB HYDROCHLORIDE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
DA87705X9K	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
3ecafc1e-979a-4aff-a276-18fc0b110491	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
59651-530-03	Erlotinib	30 in 1 BOTTLE	TABLET, FILM COATED	30	1
59651-530-10	Erlotinib	1 in 1 CARTON	TABLET, FILM COATED	1	1
59651-530-10	Erlotinib	10 in 1 BLISTER PACK	TABLET, FILM COATED	10	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59651-530	ERLOTINIB TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]	1	Current NDC, Legacy NDC, 3 package rows	20220630_3ecafc1e-979a-4aff-a276-18fc0b110491.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	Aurobindo Pharma Limited	3ecafc1e-979a-4aff-a276-18fc0b110491	2022-06-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 216342 application number: ANDA216342 ndc (product): 59651-530

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
DA87705X9K	ERLOTINIB HYDROCHLORIDE	183319-69-9	ERLOTINIB HYDROCHLORIDE
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	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603206	erlotinib 150 MG Oral Tablet	PSN	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603208	erlotinib 25 MG Oral Tablet	PSN	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603203	erlotinib 100 MG Oral Tablet	SCD	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603206	erlotinib 150 MG Oral Tablet	SCD	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603208	erlotinib 25 MG Oral Tablet	SCD	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603208	erlotinib (as erlotinib hydrochloride) 25 MG Oral Tablet	SY	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603203	erlotinib 100 MG (equivalent to erlotinib HCl 109.3 MG) Oral Tablet	SY	3ecafc1e-979a-4aff-a276-18fc0b110491	1
603206	erlotinib 150 MG (equivalent to erlotinib HCl 163.9 MG) Oral Tablet	SY	3ecafc1e-979a-4aff-a276-18fc0b110491	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
59651-530-03	59651053003	30 TABLET, FILM COATED in 1 BOTTLE (59651-530-03)		2022-06-22	0000-00-00	No	No	Current
59651-530-10	59651053010	1 BLISTER PACK in 1 CARTON (59651-530-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK	1 blister pack	2022-06-22	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Erlotinib	Aurobindo Pharma Limited \| EUGIA Pharma Specialities Limited	2022-06-06	Human Prescription Drug Label	1