Exemestane

Product NDC: 51991-005
11-digit product format: 519910005
Labeler code: 51991
Product ID: 51991-005_cb46b87b-4bbc-4aed-8656-877a480061af
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Exemestane
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Breckenridge Pharmaceutical, Inc.
Application: ANDA211031
Marketing category: ANDA
Marketing start: 2019-12-19
Substance: EXEMESTANE
Active strength: 25 mg/1
Pharmacologic classes: Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	51991-005	51991-005-33	D	Discontinued by firm		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 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A211031-001	EXEMESTANE	EXEMESTANE	25MG	TABLET / ORAL	AB		2019-02-21

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A211031-001	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	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211031-001	EXEMESTANE	25MG	TABLET / ORAL		2019-02-21	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211031-001	EXEMESTANE	25MG	TABLET / ORAL		2019-02-21	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211031-001	EXEMESTANE	25MG	TABLET / ORAL		2019-02-21	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211031-001	EXEMESTANE	25MG	TABLET / ORAL		2019-02-21	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211031-001	EXEMESTANE	25MG	TABLET / ORAL	AB	2019-02-21	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A211031-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211031-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211031-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211031-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211031-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211031-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211031-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211031-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211031-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211031-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211031-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211031-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211031-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211031-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211031-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211031-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211031-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211031-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211031-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211031-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211031-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211031-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211031-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211031-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211031-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211031-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211031-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211031-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211031-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211031-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211031-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211031-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211031-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211031-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211031-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A211031-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A211031-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A211031-001	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
EXEMESTANE	25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
NY22HMQ4BX	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310261	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
4e3fd382-19f5-4ded-ab22-39d5b1b2f366	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
1fe6d34b-d50f-eeb9-bd0c-3f0d6b635985	Product name	9	20230126
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
51991-005-33	Exemestane	30 in 1 BOTTLE	TABLET, FILM COATED	30		10
51991-005-90	Exemestane	90 in 1 BOTTLE	TABLET, FILM COATED	90		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51991-005-33	EA - Each	51991-005	f306df0f-d83e-4df7-8dd4-e6110bd23e71	1	2020-01-03
51991-005-90	EA - Each	51991-005	5ec11b66-dab9-47fa-a9c1-8713506f7420	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
51991-005	EXEMESTANE TABLET, FILM COATED [BRECKENRIDGE PHARMACEUTICAL, INC.]	10	Current NDC, Legacy NDC, 2 package rows	20250115_4e3fd382-19f5-4ded-ab22-39d5b1b2f366.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Exemestane	EXEMESTANE	Breckenridge Pharmaceutical, Inc.	4e3fd382-19f5-4ded-ab22-39d5b1b2f366	2024-09-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211031 application number: ANDA211031 ndc (product): 51991-005
Exemestane	EXEMESTANE	Bryant Ranch Prepack	1841ec12-3f4f-4b87-b719-fd0b4d9eaffb	2024-05-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211031 application number: ANDA211031

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
NY22HMQ4BX	EXEMESTANE	107868-30-4	EXEMESTANE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310261	exemestane 25 MG Oral Tablet	PSN	1841ec12-3f4f-4b87-b719-fd0b4d9eaffb	104
310261	exemestane 25 MG Oral Tablet	SCD	1841ec12-3f4f-4b87-b719-fd0b4d9eaffb	104
310261	exemestane 25 MG Oral Tablet	PSN	4e3fd382-19f5-4ded-ab22-39d5b1b2f366	10
310261	exemestane 25 MG Oral Tablet	SCD	4e3fd382-19f5-4ded-ab22-39d5b1b2f366	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
51991-005-33	51991000533	30 TABLET, FILM COATED in 1 BOTTLE (51991-005-33)	2019-12-19	0000-00-00	No	No	Current
51991-005-90	51991000590	90 TABLET, FILM COATED in 1 BOTTLE (51991-005-90)	2020-11-15	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Exemestane	Breckenridge Pharmaceutical, Inc. \| MSN Laboratories Private Limited	2024-09-12	HUMAN PRESCRIPTION DRUG LABEL	10
Exemestane	Bryant Ranch Prepack	2024-05-29	HUMAN PRESCRIPTION DRUG LABEL	104