Anastrozole

Product NDC
45865-909
11-digit product format
458650909
Labeler code
45865
Product ID
45865-909_7d792fea-6bfa-0994-e053-2a91aa0a20c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
medsource pharmaceuticals
Application
ANDA090568
Marketing category
ANDA
Marketing start
2010-06-22
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
2019-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct45865-909IInactivated by FDA2026-08-17
excluded packagepackage45865-90945865-909-30IInactivated by FDA2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 42 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage45865-909-30d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage45865-909-30f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage45865-909-302ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage45865-909-30a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage45865-909-30cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage45865-909-30cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage45865-909-30302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage45865-909-30ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage45865-909-300efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage45865-909-30ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage45865-909-30367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage45865-909-30557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage45865-909-308af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage45865-909-30834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage45865-909-301332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage45865-909-30fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage45865-909-3086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage45865-909-30bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage45865-909-308dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage45865-909-30e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage45865-909-309bebd1f3094a…5416666fcb17…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A090568-001ANASTROZOLEANASTROZOLE1MGTABLET / ORALAB2010-06-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A090568-001AB

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A090568-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A090568-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090568-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A090568-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090568-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090568-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090568-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090568-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090568-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090568-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090568-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090568-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090568-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090568-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090568-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090568-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090568-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090568-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090568-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090568-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090568-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090568-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A090568-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090568-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090568-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090568-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090568-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090568-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090568-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090568-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090568-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090568-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090568-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090568-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090568-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A090568-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A090568-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090568-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090568-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090568-001AB1e64feba35796…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9495fd23-86bb-d8f7-ae78-6dfe2f4dae2dProduct name320210204

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-909-30Anastrozole30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-909ANASTROZOLE TABLET [MEDSOURCE PHARMACEUTICALS]1Legacy NDC, 1 package rows20181221_7d792fea-6bf9-0994-e053-2a91aa0a20c1.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.aabd8f88-2b52-4d43-8dc6-61605988c4dc2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEAsclemed USA, Inc.b964f555-25d2-47ad-8942-f195f062445c2026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEAccord Healthcare Inc.03586c40-eb32-45c5-beb7-6762a6b787902026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.e3b5fc92-9189-6944-e053-2a95a90a1c9f2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
ANASTROZOLEANASTROZOLEDirect_Rxf37db328-bb81-9df9-e053-2a95a90a6f432025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.5a2d5052-95ce-d103-e053-2991aa0aa4be2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEBryant Ranch Prepack19251d0b-279a-49f5-99b2-0e74d7cca4792024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.a0acddf1-a973-bf37-e053-2995a90a0bd52024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEA-S Medication Solutions03fb3108-1856-466d-bf88-0eac961395512024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.ef6c9f7c-a1b0-3fee-e053-2995a90ab2c42024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEProficient Rx LPc7a36fd8-530e-4c63-97d5-0f80fab5880e2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN7d792fea-6bf9-0994-e053-2a91aa0a20c11
199224anastrozole 1 MG Oral TabletSCD7d792fea-6bf9-0994-e053-2a91aa0a20c11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
45865-909-304586509093030 in 1 BOTTLE, PLASTICHistorical