Anastrozole

Product NDC: 76420-004
11-digit product format: 764200004
Labeler code: 76420
Product ID: 76420-004_4ad5b64f-c4f3-4aa0-e063-6394a90a8a21
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anastrozole
Dosage form: TABLET
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA090568
Marketing category: ANDA
Marketing start: 2010-06-22
Substance: ANASTROZOLE
Active strength: 1 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 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
A090568-001	ANASTROZOLE	ANASTROZOLE	1MG	TABLET / ORAL	AB		2010-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090568-001	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	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`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	A090568-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090568-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090568-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090568-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090568-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090568-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090568-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090568-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090568-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090568-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090568-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090568-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090568-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090568-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090568-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090568-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090568-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090568-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090568-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090568-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090568-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090568-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090568-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090568-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090568-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090568-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090568-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090568-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090568-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090568-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090568-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090568-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090568-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090568-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090568-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090568-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090568-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090568-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090568-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090568-001	AB	1	`e64feba35796…`

Additional Listing Data#

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

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
b964f555-25d2-47ad-8942-f195f062445c	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	SPL version
76420-004-12	Anastrozole	120 in 1 BOTTLE, PLASTIC	TABLET	120	3
76420-004-15	Anastrozole	150 in 1 BOTTLE, PLASTIC	TABLET	150	3
76420-004-20	Anastrozole	20 in 1 BOTTLE, PLASTIC	TABLET	20	3
76420-004-30	Anastrozole	30 in 1 BOTTLE, PLASTIC	TABLET	30	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-004	ANASTROZOLE TABLET [ASCLEMED USA, INC.]	2	Current NDC, Legacy NDC, 4 package rows	20221013_b964f555-25d2-47ad-8942-f195f062445c.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anastrozole	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	aabd8f88-2b52-4d43-8dc6-61605988c4dc	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	Asclemed USA, Inc.	b964f555-25d2-47ad-8942-f195f062445c	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568 ndc (product): 76420-004
Anastrozole	ANASTROZOLE	Accord Healthcare Inc.	03586c40-eb32-45c5-beb7-6762a6b78790	2026-02-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	e3b5fc92-9189-6944-e053-2a95a90a1c9f	2025-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
ANASTROZOLE	ANASTROZOLE	Direct_Rx	f37db328-bb81-9df9-e053-2a95a90a6f43	2025-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	5a2d5052-95ce-d103-e053-2991aa0aa4be	2024-12-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	Bryant Ranch Prepack	19251d0b-279a-49f5-99b2-0e74d7cca479	2024-08-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	a0acddf1-a973-bf37-e053-2995a90a0bd5	2024-06-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	A-S Medication Solutions	03fb3108-1856-466d-bf88-0eac96139551	2024-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	ef6c9f7c-a1b0-3fee-e053-2995a90ab2c4	2024-04-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568
Anastrozole	ANASTROZOLE	Proficient Rx LP	c7a36fd8-530e-4c63-97d5-0f80fab5880e	2023-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090568 application number: ANDA090568

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	b964f555-25d2-47ad-8942-f195f062445c	3
199224	anastrozole 1 MG Oral Tablet	SCD	b964f555-25d2-47ad-8942-f195f062445c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-004-12	76420000412	120 TABLET in 1 BOTTLE, PLASTIC (76420-004-12)	120 tablet	2019-12-24	0000-00-00	No	No	Current
76420-004-15	76420000415	150 TABLET in 1 BOTTLE, PLASTIC (76420-004-15)	150 tablet	2019-12-24	0000-00-00	No	No	Current
76420-004-20	76420000420	20 TABLET in 1 BOTTLE, PLASTIC (76420-004-20)	20 tablet	2019-12-24	0000-00-00	No	No	Current
76420-004-30	76420000430	30 TABLET in 1 BOTTLE, PLASTIC (76420-004-30)	30 tablet	2019-12-24	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Anastrozole	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2026-02-14	HUMAN PRESCRIPTION DRUG LABEL	3