Anastrozole

Product NDC: 82804-162
11-digit product format: 828040162
Labeler code: 82804
Product ID: 82804-162_db39f10e-5444-4e57-97b2-0358001df04a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anastrozole Tablets
Dosage form: TABLET
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA206037
Marketing category: ANDA
Marketing start: 2019-02-28
Substance: ANASTROZOLE
Active strength: 1 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
A206037-001	ANASTROZOLE	ANASTROZOLE	1MG	TABLET / ORAL	AB		2018-11-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A206037-001	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	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206037-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2018-11-09	`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	A206037-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A206037-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A206037-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A206037-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A206037-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A206037-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A206037-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A206037-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A206037-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A206037-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A206037-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A206037-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A206037-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A206037-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A206037-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A206037-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A206037-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A206037-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A206037-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A206037-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A206037-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A206037-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A206037-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A206037-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A206037-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A206037-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A206037-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A206037-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A206037-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A206037-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A206037-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A206037-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A206037-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A206037-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A206037-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A206037-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A206037-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A206037-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A206037-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A206037-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ANASTROZOLE	1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2Z07MYW1AZ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
199224	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
2df2aa01-1fe7-477c-9a23-699879b0b918	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9495fd23-86bb-d8f7-ae78-6dfe2f4dae2d	Product name	3	20210204

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82804-162-30	Anastrozole	30 in 1 BOTTLE	TABLET	30		2
82804-162-90	Anastrozole	90 in 1 BOTTLE	TABLET	90		2

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-162-30	EA - Each	82804-162	589134fd-fcd8-4a6d-8dc8-43a98fe90640	1	2024-12-10
82804-162-90	EA - Each	82804-162	b161f01f-a558-4675-9723-668ffd9e55e3	1	2026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-162	ANASTROZOLE (ANASTROZOLE TABLETS) TABLET [PROFICIENT RX LP]	1	Current NDC, 2 package rows	20241030_2df2aa01-1fe7-477c-9a23-699879b0b918.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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anastrozole	ANASTROZOLE	Direct_Rx	58390d1f-7390-a21f-e063-6294a90a0479	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037
Anastrozole	ANASTROZOLE TABLETS	ASCLEMED USA INC.	39df1668-8344-4c42-9bd7-7907bd571f6e	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037
Anastrozole	ANASTROZOLE TABLETS	NuCare Pharmaceuticals, Inc.	513e8413-af48-4acc-e063-6294a90a24b4	2026-05-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037
Anastrozole	ANASTROZOLE TABLETS	Avet Pharmaceuticals Inc	f86d2158-b078-3f74-e053-6394a90aa4b6	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037
Anastrozole	ANASTROZOLE TABLETS	Yiling Pharmaceutical, Inc.	7b3da447-8e7c-2aaa-e053-2a91aa0a2821	2025-12-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037
Anastrozole	ANASTROZOLE	Chartwell RX, LLC	da6ae05c-81e9-492a-a4c9-be3f1f367b59	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037
Anastrozole	ANASTROZOLE TABLETS	Proficient Rx LP	2df2aa01-1fe7-477c-9a23-699879b0b918	2025-09-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037 ndc (product): 82804-162
Anastrozole	ANASTROZOLE TABLETS	Upsher-Smith Laboratories, LLC	7e0bd2cc-d3cc-403f-a6b6-4597ccb2f685	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 206037 application number: ANDA206037

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
2Z07MYW1AZ	ANASTROZOLE	120511-73-1	ANASTROZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
199224	anastrozole 1 MG Oral Tablet	PSN	2df2aa01-1fe7-477c-9a23-699879b0b918	2
199224	anastrozole 1 MG Oral Tablet	SCD	2df2aa01-1fe7-477c-9a23-699879b0b918	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82804-162-30	82804016230	30 TABLET in 1 BOTTLE (82804-162-30)	30 tablet	2024-10-25	No	No	Current
82804-162-90	82804016290	90 TABLET in 1 BOTTLE (82804-162-90)	90 tablet	2025-09-16	No	No	Current