LETROZOLE

Product NDC: 50090-8002
11-digit product format: 500908002
Labeler code: 50090
Product ID: 50090-8002_c285142b-3135-4f3b-ac1b-7f97410f8e40
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: LETROZOLE
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA200161
Marketing category: ANDA
Marketing start: 2011-06-04
Substance: LETROZOLE
Active strength: 2.5 mg/1
Pharmacologic classes: Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A200161-001	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
A200161-001	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 · 43 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
2026-09-14 22:38:34	2026-08	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200161-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2011-06-03	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A200161-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A200161-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A200161-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A200161-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A200161-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A200161-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A200161-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A200161-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A200161-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A200161-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A200161-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A200161-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A200161-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A200161-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A200161-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A200161-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A200161-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A200161-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A200161-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A200161-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A200161-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A200161-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A200161-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A200161-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A200161-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A200161-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A200161-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A200161-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A200161-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A200161-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A200161-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A200161-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A200161-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A200161-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A200161-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A200161-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A200161-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A200161-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A200161-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A200161-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: LETROZOLE
Listing expiration: 2027-12-31

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
3baa3912-3e64-473b-8ec6-8557aa7907c2	Available on FDA.report

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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
LETROZOLE	LETROZOLE	Bryant Ranch Prepack	3cc750a5-cc88-4b42-b4ab-a87e760f291d	2026-08-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200161 application number: ANDA200161
LETROZOLE	LETROZOLE	Breckenridge Pharmaceutical, Inc.	63e54b62-a30d-4a56-9215-75e7a0b0bf02	2026-08-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200161 application number: ANDA200161
LETROZOLE	LETROZOLE	A-S Medication Solutions	3baa3912-3e64-473b-8ec6-8557aa7907c2	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200161 application number: ANDA200161 ndc (product): 50090-8002
LETROZOLE	LETROZOLE	AvPAK	93f317f1-96d1-498e-e053-2995a90ac60d	2026-01-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200161 application number: ANDA200161
Letrozole	LETROZOLE	Natco Pharma Limited	35c73219-c39e-4e10-b944-76009b061e79	2020-11-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 200161 application number: ANDA200161

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-8002-0	50090800200	90 TABLET in 1 BOTTLE (50090-8002-0)	90 tablet	2026-06-24	No	No	Current