ANASTROZOLE

Product NDC: 42291-016
11-digit product format: 422910016
Labeler code: 42291
Product ID: 42291-016_48481e73-92ad-d506-e063-6394a90a6518
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ANASTROZOLE
Dosage form: TABLET
Route: ORAL
Labeler: AvKARE
Application: ANDA079220
Marketing category: ANDA
Marketing start: 2023-02-06
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 1.

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
A079220-001	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
A079220-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079220-001	ANASTROZOLE	1MG	TABLET / ORAL	AB	2010-06-28	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A079220-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A079220-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A079220-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A079220-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A079220-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A079220-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A079220-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A079220-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A079220-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A079220-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A079220-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A079220-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A079220-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A079220-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A079220-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A079220-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A079220-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A079220-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A079220-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A079220-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A079220-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A079220-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A079220-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A079220-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A079220-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A079220-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A079220-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A079220-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A079220-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A079220-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A079220-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A079220-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A079220-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A079220-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A079220-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A079220-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A079220-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A079220-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A079220-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A079220-001	AB	1	`cb3db0bc1861…`

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
f40b925f-9f43-321d-e053-2a95a90aca8b	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
42291-016-30	ANASTROZOLE	30 in 1 BOTTLE	TABLET	30		2
42291-016-90	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
42291-016-30	EA - Each	42291-016	14c76e9f-1b86-4631-a216-829c724409f4	1	2023-03-13
42291-016-90	EA - Each	42291-016	351d46da-2988-4339-bb32-4a8c02eedd15	1	2023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
42291-016	ANASTROZOLE TABLET [AVKARE]	1	Current NDC, 2 package rows	20230207_f40b925f-9f43-321d-e053-2a95a90aca8b.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ANASTROZOLE	ANASTROZOLE	Breckenridge Pharmaceutical, Inc.	ca9d4aff-ffdf-4a46-ad20-e47e5886a19e	2026-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	69be1c52-93db-e2c3-e053-2a91aa0af774	2026-05-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	AvPAK	94a46579-0d79-89c7-e053-2995a90a6467	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	AvKARE	f40b925f-9f43-321d-e053-2a95a90aca8b	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220 ndc (product): 42291-016
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals, Inc.	362034e9-2830-19a5-e063-6394a90a8dfb	2025-12-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	33f14d51-de4e-cbe4-e063-6294a90a964b	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	A-S Medication Solutions	90d9dbb4-b1ba-431e-b588-1a1a04cf1444	2025-04-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	5d4f90d4-e535-4681-a863-3d774a2064e6	2025-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
ANASTROZOLE	ANASTROZOLE	Bryant Ranch Prepack	1d1d5818-1594-4f54-90a9-ae9a9afcdc67	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220
Anastrozole	ANASTROZOLE	Natco Pharma Limited	df55dc4c-9a53-4a37-a90f-c4e88d458b89	2020-10-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 079220 application number: ANDA079220

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	f40b925f-9f43-321d-e053-2a95a90aca8b	2
199224	anastrozole 1 MG Oral Tablet	SCD	f40b925f-9f43-321d-e053-2a95a90aca8b	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
42291-016-30	42291001630	30 TABLET in 1 BOTTLE (42291-016-30)	30 tablet	2023-02-06	No	No	Current
42291-016-90	42291001690	90 TABLET in 1 BOTTLE (42291-016-90)	90 tablet	2023-02-06	No	No	Current