Anastrozole

Product NDC
16571-421
11-digit product format
165710421
Labeler code
16571
Product ID
16571-421_30c70050-54a8-4a24-a4da-21c2b29278b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharmaceuticals, Inc.
Application
ANDA079220
Marketing category
ANDA
Marketing start
2010-06-01
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#

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 productproduct16571-421DDiscontinued by firm2026-08-17
excluded packagepackage16571-42116571-421-03DDiscontinued by firm2026-08-17

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 · 24 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 packagepackage16571-421-03d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage16571-421-03f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage16571-421-032ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage16571-421-03a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage16571-421-03cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage16571-421-03cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage16571-421-03302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage16571-421-03ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage16571-421-030efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage16571-421-03ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage16571-421-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage16571-421-03557ba5c1ecfa…9c80585c8c6e…

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
A079220-001ANASTROZOLEANASTROZOLE1MGTABLET / 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
A079220-001AB

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 06:07:402026-07A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-2887673890dc5c…
2021-03-12 10:30 UTC2021-03A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283f01610625f2…
2019-09-15 20:21 UTC2019-09A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28b00525d2431f…
2019-07-19 19:46 UTC2019-07A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283f0d92c62455…
2023-05-13 08:27 UTC2023-05A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28053a50430f4f…
2023-01-26 05:58 UTC2023-01A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079220-001ANASTROZOLE1MGTABLET / 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 06:07:402026-07A079220-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A079220-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A079220-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A079220-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A079220-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A079220-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A079220-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A079220-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A079220-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A079220-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A079220-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A079220-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A079220-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A079220-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A079220-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A079220-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A079220-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A079220-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A079220-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A079220-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A079220-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A079220-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A079220-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A079220-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A079220-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A079220-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A079220-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A079220-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A079220-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A079220-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A079220-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A079220-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A079220-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A079220-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A079220-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A079220-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A079220-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A079220-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A079220-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A079220-001AB1e64feba35796…

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-421-03EA - Each16571-421c9b4f85c-e4d3-49bc-98bb-f590a0f3156e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET [PACK PHARMACEUTICALS, LLC]2

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANASTROZOLEANASTROZOLEPD-Rx Pharmaceuticals, Inc.5d4f90d4-e535-4681-a863-3d774a2064e62026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLEBreckenridge Pharmaceutical, Inc.ca9d4aff-ffdf-4a46-ad20-e47e5886a19e2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLENuCare Pharmaceuticals,Inc.69be1c52-93db-e2c3-e053-2a91aa0af7742026-05-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLEAvPAK94a46579-0d79-89c7-e053-2995a90a64672026-03-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLEAvKAREf40b925f-9f43-321d-e053-2a95a90aca8b2026-01-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLENuCare Pharmaceuticals, Inc.362034e9-2830-19a5-e063-6394a90a8dfb2025-12-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLENuCare Pharmaceuticals,Inc.33f14d51-de4e-cbe4-e063-6294a90a964b2025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLEA-S Medication Solutions90d9dbb4-b1ba-431e-b588-1a1a04cf14442025-04-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ANASTROZOLEANASTROZOLEBryant Ranch Prepack1d1d5818-1594-4f54-90a9-ae9a9afcdc672024-05-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
AnastrozoleANASTROZOLENatco Pharma Limiteddf55dc4c-9a53-4a37-a90f-c4e88d458b892020-10-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-421-031657104210330 TABLET in 1 BOTTLE (16571-421-03) 30 tablet2019-05-170000-00-00NoNoCurrent