Anastrozole

Product NDC: 71335-3145
11-digit product format: 713353145
Labeler code: 71335
Product ID: 71335-3145_51d68c25-5310-4c4d-8c95-83e3c17815f3
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Anastrozole
Dosage form: TABLET, COATED
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA078921
Marketing category: ANDA
Marketing start: 2010-06-27
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 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
A078921-001	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
A078921-001	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	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078921-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`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	A078921-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078921-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078921-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078921-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078921-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078921-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078921-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078921-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078921-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078921-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078921-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078921-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078921-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078921-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078921-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078921-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078921-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078921-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078921-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078921-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078921-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A078921-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A078921-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A078921-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A078921-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A078921-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A078921-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A078921-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A078921-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A078921-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A078921-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A078921-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A078921-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A078921-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A078921-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A078921-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A078921-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A078921-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A078921-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A078921-001	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: 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
f5b53383-0366-4ae2-9aa4-88b56c0bbd07	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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anastrozole	ANASTROZOLE	Bryant Ranch Prepack	f5b53383-0366-4ae2-9aa4-88b56c0bbd07	2026-06-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078921 application number: ANDA078921 ndc (product): 71335-3145
Anastrozole	ANASTROZOLE	American Health Packaging	dface914-5135-4136-82f4-75429b496a35	2025-08-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078921 application number: ANDA078921
Anastrozole	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	b023a9f2-1a99-4b40-a953-edac7e3a79bf	2025-02-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078921 application number: ANDA078921
Anastrozole	ANASTROZOLE	BluePoint Laboratories	3cd04ed6-7c5a-4c4a-9955-ee40839dfea0	2025-02-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078921 application number: ANDA078921
Anastrozole	ANASTROZOLE	Zydus Pharmaceuticals USA Inc.	ca16f8de-d9a5-4c6c-957b-ae28497b67ac	2025-01-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078921 application number: ANDA078921
Anastrozole	ANASTROZOLE	Zydus Lifesciences Limited	965c4cb1-f6b8-47ac-bf13-c36639aa908f	2024-11-25		Exact identifier application applno (ANDA): 078921 application number: ANDA078921

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71335-3145-0	71335314500	28 TABLET, COATED in 1 BOTTLE (71335-3145-0)	2026-06-18	No	No	Current
71335-3145-1	71335314501	30 TABLET, COATED in 1 BOTTLE (71335-3145-1)	2026-06-18	No	No	Current
71335-3145-2	71335314502	20 TABLET, COATED in 1 BOTTLE (71335-3145-2)	2026-06-18	No	No	Current
71335-3145-3	71335314503	90 TABLET, COATED in 1 BOTTLE (71335-3145-3)	2026-06-18	No	No	Current
71335-3145-4	71335314504	4 TABLET, COATED in 1 BOTTLE (71335-3145-4)	2026-06-18	No	No	Current
71335-3145-5	71335314505	6 TABLET, COATED in 1 BOTTLE (71335-3145-5)	2026-06-18	No	No	Current
71335-3145-6	71335314506	10 TABLET, COATED in 1 BOTTLE (71335-3145-6)	2026-06-18	No	No	Current
71335-3145-7	71335314507	40 TABLET, COATED in 1 BOTTLE (71335-3145-7)	2026-06-18	No	No	Current
71335-3145-8	71335314508	12 TABLET, COATED in 1 BOTTLE (71335-3145-8)	2026-06-18	No	No	Current
71335-3145-9	71335314509	14 TABLET, COATED in 1 BOTTLE (71335-3145-9)	2026-06-18	No	No	Current