Letrozole

Product NDC: 42254-243
11-digit product format: 422540243
Labeler code: 42254
Product ID: 42254-243_0193faa4-9b02-4ccd-9751-de6124cc8c68
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Letrozole
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Rebel Distributors Corp
Application: ANDA090289
Marketing category: ANDA
Marketing start: 2011-06-03
Marketing end: 0000-00-00
Substance: LETROZOLE
Active strength: 3 mg/1
Pharmacologic classes: Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
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	42254-243		I	Inactivated by FDA		2026-08-17
excluded package	package	42254-243	42254-243-30	I	Inactivated by FDA		2026-08-17

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 · 44 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	42254-243-30	`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	42254-243-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	42254-243-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	42254-243-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	42254-243-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	42254-243-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	42254-243-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	42254-243-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	42254-243-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	42254-243-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	42254-243-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	42254-243-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
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	42254-243-30	`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	42254-243-30	`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	42254-243-30	`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	42254-243-30	`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	42254-243-30	`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	42254-243-30	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	42254-243-30	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	42254-243-30	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	42254-243-30	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	42254-243-30	`110d247fa046…`	`a55b01930146…`

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
A090289-001	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
A090289-001	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	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090289-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090289-001	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	A090289-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090289-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090289-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090289-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090289-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090289-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090289-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090289-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090289-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090289-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090289-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090289-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090289-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090289-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090289-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090289-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090289-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090289-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090289-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090289-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090289-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090289-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090289-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090289-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090289-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090289-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090289-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090289-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090289-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090289-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090289-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090289-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090289-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090289-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090289-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090289-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090289-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090289-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090289-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090289-001	AB	1	`e64feba35796…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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
42254-243-30	2019-09-24	C162847	48780-1	9350213a-3c8c-c013-e053-90daa90a1393	These highlights do not include all the information needed to use letrozole tablets USP safely and effectively. See full prescribing information for letrozole tablets USP. LETROZOLE tablets USP 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
42254-243-30	Letrozole	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
42254-243-30	EA - Each	42254-243	f51ee947-ae48-4579-89ec-3e80401d70a7	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LETROZOLE	ACTIVE INGREDIENT	7LKK855W8I	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LETROZOLE	ACTIVE MOIETY	7LKK855W8I	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FD&C YELLOW NO. 5	INACTIVE INGREDIENT	I753WB2F1M	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYETHYLENE GLYCOLS	INACTIVE INGREDIENT	3WJQ0SDW1A	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
POLYVINYL ALCOHOL	INACTIVE INGREDIENT	532B59J990	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42254-243	LETROZOLE TABLET, FILM COATED [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20130228_0193faa4-9b02-4ccd-9751-de6124cc8c68.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Letrozole	LETROZOLE	AvKARE	1524730f-e37d-478c-1956-b113b3ca42a8	2025-11-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090289 application number: ANDA090289
Letrozole	LETROZOLE	Teva Pharmaceuticals USA, Inc.	8ebda73d-82a3-4b17-8a81-a1f258003d32	2024-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090289 application number: ANDA090289
Letrozole	LETROZOLE	Proficient Rx LP	e1390a0d-0280-49a5-a2d4-d2e13e9952ca	2021-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090289 application number: ANDA090289

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	0193faa4-9b02-4ccd-9751-de6124cc8c68	1
200064	letrozole 2.5 MG Oral Tablet	SCD	0193faa4-9b02-4ccd-9751-de6124cc8c68	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
42254-243-30	42254024330	30 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Letrozole	Rebel Distributors Corp \| PSS World Medical, Inc. \| STAT RX USA LLC \| Dispensing Solutions, Inc. \| SCRIPT PAK \| Keltman Pharmaceuticals, Inc. \| Rebel Distirbutors Corp.	2012-06-20	HUMAN PRESCRIPTION DRUG LABEL	1