ANASTROZOLE

Product NDC: 76519-1224
Requested package NDC: 76519-1224-3
11-digit product format: 765191224
Labeler code: 76519
Product ID: 76519-1224_8270c509-4c1d-bfd8-e053-2991aa0abb90
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: ANASTROZOLE
Dosage form: TABLET
Route: ORAL
Labeler: H.J. Harkins Company, Inc.
Application: ANDA090568
Marketing category: ANDA
Marketing start: 2019-02-15
Marketing end: 0000-00-00
Substance: ANASTROZOLE
Active strength: 1 mg/1
Pharmacologic classes: Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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	76519-1224	76519-1224-3	I	Inactivated by FDA		2026-07-31

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
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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-08-01 22:54:32	2026-06	A090568-001	ANASTROZOLE	1MG	TABLET / ORAL	AB		2010-06-28	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	A090568-001	AB	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 2 · 40 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 rxcui: 199224 unii: 2Z07MYW1AZ
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 ndc (package): 72789-008-15 ndc (package): 72789-008-90 ndc (product): 72789-008 rxcui: 199224 spl id: 56079409-539c-a1f9-e063-6394a90a8c49 spl set id: aabd8f88-2b52-4d43-8dc6-61605988c4dc unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE	PD-Rx Pharmaceuticals, Inc.	54da5c12-cfaf-7a14-e063-6394a90a3635	2026-06-22	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE	Bryant Ranch Prepack	f5b53383-0366-4ae2-9aa4-88b56c0bbd07	2026-06-18	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE TABLETS	ASCLEMED USA INC.	39df1668-8344-4c42-9bd7-7907bd571f6e	2026-06-15	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals,Inc.	69be1c52-93db-e2c3-e053-2a91aa0af774	2026-05-28	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE TABLETS	NuCare Pharmaceuticals, Inc.	513e8413-af48-4acc-e063-6294a90a24b4	2026-05-07	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
ANASTROZOLE	ANASTROZOLE	AvPAK	94a46579-0d79-89c7-e053-2995a90a6467	2026-03-10	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
ARIMIDEX	ANASTROZOLE	ANI Pharmaceuticals, Inc.	acbfaaa9-503c-4691-9828-76a7146ed6de	2026-03-02	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
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 (package): 76420-004-20 ndc (package): 76420-004-12 ndc (package): 76420-004-30 ndc (package): 76420-004-15 ndc (product): 76420-004 rxcui: 199224 spl id: 4ad5b64f-c4f3-4aa0-e063-6394a90a8a21 spl set id: b964f555-25d2-47ad-8942-f195f062445c unii: 2Z07MYW1AZ
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 ndc (package): 16729-035-16 ndc (package): 16729-035-15 ndc (package): 16729-035-17 ndc (package): 16729-035-10 ndc (product): 16729-035 rxcui: 199224 spl id: 4a900d2c-12d3-6bfa-e063-6294a90af009 spl set id: 03586c40-eb32-45c5-beb7-6762a6b78790 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE	AvKARE	a0c2672b-e07b-4f6c-e053-2a95a90a2e5d	2026-01-14	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
ANASTROZOLE	ANASTROZOLE	AvKARE	f40b925f-9f43-321d-e053-2a95a90aca8b	2026-01-13	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE TABLETS	Avet Pharmaceuticals Inc	f86d2158-b078-3f74-e053-6394a90aa4b6	2025-12-29	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE TABLETS	Yiling Pharmaceutical, Inc.	7b3da447-8e7c-2aaa-e053-2a91aa0a2821	2025-12-29	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
ANASTROZOLE	ANASTROZOLE	NuCare Pharmaceuticals, Inc.	362034e9-2830-19a5-e063-6394a90a8dfb	2025-12-09	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE	Chartwell RX, LLC	da6ae05c-81e9-492a-a4c9-be3f1f367b59	2025-12-09	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE TABLETS	Proficient Rx LP	2df2aa01-1fe7-477c-9a23-699879b0b918	2025-09-01	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE	American Health Packaging	dface914-5135-4136-82f4-75429b496a35	2025-08-29	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ
Anastrozole	ANASTROZOLE TABLETS	Upsher-Smith Laboratories, LLC	7e0bd2cc-d3cc-403f-a6b6-4597ccb2f685	2025-07-09	Warnings, Adverse reactions	Exact identifier rxcui: 199224 unii: 2Z07MYW1AZ

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
76519-1224-3	2022-01-28	C162847	48780-1	d6a99b39-6a3f-a426-e053-dadaa90af4c2	1224 ANASTROZOLE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
76519-1224-3	ANASTROZOLE	30 in 1 BOTTLE	TABLET	30		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76519-1224	ANASTROZOLE TABLET [H.J. HARKINS COMPANY, INC.]	1	Legacy NDC, 1 package rows	20190308_8270c509-4c1c-bfd8-e053-2991aa0abb90.zip

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	8270c509-4c1c-bfd8-e053-2991aa0abb90	1
199224	anastrozole 1 MG Oral Tablet	SCD	8270c509-4c1c-bfd8-e053-2991aa0abb90	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
76519-1224-3	76519122403	30 TABLET in 1 BOTTLE (76519-1224-3)	30 tablet	2019-02-15	0000-00-00	No	No	Current