Letrozole

Product NDC: 68071-5264
11-digit product format: 680715264
Labeler code: 68071
Product ID: 68071-5264_2a849ae9-3398-4642-e063-6394a90a1ca4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: letrozole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA090934
Marketing category: ANDA
Marketing start: 2011-06-02
Substance: LETROZOLE
Active strength: 2.5 mg/1
Pharmacologic classes: Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 12 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
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68071-5264-3	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68071-5264-3	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68071-5264-3	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68071-5264-3	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68071-5264-3	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68071-5264-3	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090934-001	LETROZOLE	LETROZOLE	2.5MG	TABLET / ORAL	AB		2011-06-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090934-001	AB

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 2 · 42 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
2026-08-18 06:07:40	2026-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090934-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090934-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090934-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090934-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090934-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090934-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090934-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090934-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090934-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090934-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090934-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090934-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090934-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090934-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090934-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090934-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090934-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090934-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090934-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090934-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090934-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090934-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090934-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090934-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090934-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090934-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090934-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090934-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090934-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090934-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090934-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090934-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090934-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090934-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090934-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090934-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090934-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090934-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090934-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090934-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090934-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
LETROZOLE	2.5 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7LKK855W8I	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
200064	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
a707ec4b-8d26-55c2-e053-2a95a90a2e07	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d50ad188-a2a9-1aec-5d6c-f8612e9e5867	Product name	4	20190528
4f1e9b6f-5fe1-47c9-ab31-3c39ee923083	Product name	2	20170713

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-5264-3	2024-07-03	C162847	48780-1	d6a99b39-598e-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. LETROZOLE tablets, for oral use Initial U.S. Approval: 1997
68071-5264-3	2022-01-28	C162847	48780-1	d6a99b39-598e-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use letrozole tablets safely and effectively. See full prescribing information for letrozole tablets. LETROZOLE tablets, for oral use Initial U.S. Approval: 1997

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68071-5264-3	Letrozole	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68071-5264	LETROZOLE TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]	4	Current NDC, Legacy NDC, 1 package rows	20250101_a707ec4b-8d26-55c2-e053-2a95a90a2e07.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Letrozole	LETROZOLE	A-S Medication Solutions	065cc89f-3a3f-4d78-b9f6-1c32a77ceb1c	2026-06-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934
Letrozole	LETROZOLE	Bryant Ranch Prepack	26dcb6ee-74d8-4804-b151-79a41484979b	2026-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934
Letrozole	LETROZOLE	Accord Healthcare, Inc.	c391fe11-fd47-4a35-af6d-c823ab7b8838	2026-02-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934
Letrozole	LETROZOLE	ATLANTIC BIOLOGICALS CORP.	c10bf97f-f9cf-468a-8a1f-7637f41022e4	2025-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934
Letrozole	LETROZOLE	NuCare Pharmaceuticals,Inc.	a707ec4b-8d26-55c2-e053-2a95a90a2e07	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934 ndc (product): 68071-5264
Letrozole	LETROZOLE	NuCare Pharmaceuticals,Inc.	1b408ba8-05f7-1cf1-e063-6394a90a42bc	2024-06-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090934 application number: ANDA090934

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
7LKK855W8I	LETROZOLE	112809-51-5	LETROZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
200064	letrozole 2.5 MG Oral Tablet	PSN	a707ec4b-8d26-55c2-e053-2a95a90a2e07	4
200064	letrozole 2.5 MG Oral Tablet	SCD	a707ec4b-8d26-55c2-e053-2a95a90a2e07	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-5264-3	68071526403	30 TABLET, FILM COATED in 1 BOTTLE (68071-5264-3)	2020-06-01	0000-00-00	No	No	Current