Letrozole

Product NDC: 69117-0004
11-digit product format: 691170004
Labeler code: 69117
Product ID: 69117-0004_4721d1b1-3a04-27fb-e063-6394a90a7c1a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Letrozole Tablets
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Yiling Pharmaceutical, Inc.
Application: ANDA205869
Marketing category: ANDA
Marketing start: 2019-09-05
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

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
A205869-001	LETROZOLE	LETROZOLE	2.5MG	TABLET / ORAL	AB		2018-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205869-001	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	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205869-001	LETROZOLE	2.5MG	TABLET / ORAL	AB	2018-11-14	`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	A205869-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205869-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205869-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205869-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205869-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205869-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205869-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205869-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205869-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205869-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205869-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205869-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205869-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205869-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205869-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205869-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205869-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205869-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205869-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205869-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205869-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205869-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205869-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205869-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205869-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205869-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205869-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205869-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205869-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205869-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205869-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205869-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205869-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205869-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205869-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205869-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205869-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205869-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205869-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205869-001	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
7b00e08c-9a1c-09e0-e053-2a91aa0a7638	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69117-0004-1	Letrozole	30 in 1 BOTTLE	TABLET, FILM COATED	30		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69117-0004-1	EA - Each	69117-0004	7ce4332e-ffe6-41d9-b7df-66dd07017a43	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69117-0004	LETROZOLE (LETROZOLE TABLETS) TABLET, FILM COATED [YILING PHARMACEUTICAL, INC.]	9	Current NDC, Legacy NDC, 1 package rows	20241226_7b00e08c-9a1c-09e0-e053-2a91aa0a7638.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 TABLETS	Golden State Medical Supply, Inc.	32d7dd83-a3ef-41fe-e063-6394a90ae62a	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205869 application number: ANDA205869
Letrozole	LETROZOLE TABLETS	Upsher-Smith Laboratories, LLC	2d1f18f0-2c77-407c-b702-2d1b07f92510	2026-03-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205869 application number: ANDA205869
Letrozole	LETROZOLE TABLETS	Yiling Pharmaceutical, Inc.	7b00e08c-9a1c-09e0-e053-2a91aa0a7638	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205869 application number: ANDA205869 ndc (product): 69117-0004
LETROZOLE	LETROZOLE	Chartwell RX, LLC	fa2d40a5-3504-44ef-8f5c-aa4c06308074	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205869 application number: ANDA205869
Letrozole	LETROZOLE TABLETS	Avet Pharmaceuticals Inc.	fe0e4d4b-436d-a36d-e053-6294a90a973d	2025-09-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205869 application number: ANDA205869
Letrozole	LETROZOLE TABLETS	Bryant Ranch Prepack	6fd92634-c9c5-457e-808c-a4614e8db7db	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205869 application number: ANDA205869

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	7b00e08c-9a1c-09e0-e053-2a91aa0a7638	10
200064	letrozole 2.5 MG Oral Tablet	SCD	7b00e08c-9a1c-09e0-e053-2a91aa0a7638	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69117-0004-1	69117000401	30 TABLET, FILM COATED in 1 BOTTLE (69117-0004-1)	2019-09-05	0000-00-00	Yes	No	Current