ANASTROZOLE

Product NDC
51991-620
11-digit product format
519910620
Labeler code
51991
Product ID
51991-620_d127732f-9c07-4d93-b8df-fd4019cb31e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ANASTROZOLE
Dosage form
TABLET
Route
ORAL
Labeler
Breckenridge Pharmaceutical, Inc.
Application
ANDA079220
Marketing category
ANDA
Marketing start
2010-06-28
Substance
ANASTROZOLE
Active strength
1 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
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-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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079220-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28cb3db0bc1861…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
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…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A079220-001AB1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
ANASTROZOLE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANASTROZOLE1 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2Z07MYW1AZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199224Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ca9d4aff-ffdf-4a46-ad20-e47e5886a19eAvailable on FDA.report

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51991-620-10ANASTROZOLE1000 in 1 BOTTLETABLET100012
51991-620-33ANASTROZOLE30 in 1 BOTTLETABLET3012
51991-620-90ANASTROZOLE90 in 1 BOTTLETABLET9012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51991-620-10EA - Each51991-620a1bea6ce-eeb7-4d25-a5a6-0bba38011b5a12012-07-24
51991-620-33EA - Each51991-620d3b26c99-7a71-420d-9e96-90503a09adf912012-07-24
51991-620-90EA - Each51991-620c8def5e5-b9f5-41eb-94ad-63671390832012023-05-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET [PD-RX PHARMACEUTICALS, INC.]3
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
HYPROMELLOSEINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51991-620ANASTROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.]12Current NDC, Legacy NDC, 3 package rows20250110_ca9d4aff-ffdf-4a46-ad20-e47e5886a19e.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ANASTROZOLEANASTROZOLEBreckenridge Pharmaceutical, Inc.ca9d4aff-ffdf-4a46-ad20-e47e5886a19e2026-07-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 079220
application number: ANDA079220
ndc (product): 51991-620
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
ANASTROZOLEANASTROZOLEPD-Rx Pharmaceuticals, Inc.5d4f90d4-e535-4681-a863-3d774a2064e62025-02-27Warnings, 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN1d1d5818-1594-4f54-90a9-ae9a9afcdc67104
199224anastrozole 1 MG Oral TabletSCD1d1d5818-1594-4f54-90a9-ae9a9afcdc67104
199224anastrozole 1 MG Oral TabletPSN5d4f90d4-e535-4681-a863-3d774a2064e616
199224anastrozole 1 MG Oral TabletSCD5d4f90d4-e535-4681-a863-3d774a2064e616
199224anastrozole 1 MG Oral TabletPSNca9d4aff-ffdf-4a46-ad20-e47e5886a19e12
199224anastrozole 1 MG Oral TabletSCDca9d4aff-ffdf-4a46-ad20-e47e5886a19e12
199224anastrozole 1 MG Oral TabletPSN90d9dbb4-b1ba-431e-b588-1a1a04cf14447
199224anastrozole 1 MG Oral TabletSCD90d9dbb4-b1ba-431e-b588-1a1a04cf14447
199224anastrozole 1 MG Oral TabletPSN94a46579-0d79-89c7-e053-2995a90a64675
199224anastrozole 1 MG Oral TabletSCD94a46579-0d79-89c7-e053-2995a90a64675
199224anastrozole 1 MG Oral TabletPSN362034e9-2830-19a5-e063-6394a90a8dfb2
199224anastrozole 1 MG Oral TabletPSNf40b925f-9f43-321d-e053-2a95a90aca8b2
199224anastrozole 1 MG Oral TabletSCD362034e9-2830-19a5-e063-6394a90a8dfb2
199224anastrozole 1 MG Oral TabletSCDf40b925f-9f43-321d-e053-2a95a90aca8b2
199224anastrozole 1 MG Oral TabletPSN33f14d51-de4e-cbe4-e063-6294a90a964b1
199224anastrozole 1 MG Oral TabletSCD33f14d51-de4e-cbe4-e063-6294a90a964b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51991-620-10519910620101000 TABLET in 1 BOTTLE (51991-620-10) 1000 tablet2010-06-280000-00-00NoNoCurrent
51991-620-335199106203330 TABLET in 1 BOTTLE (51991-620-33) 30 tablet2010-06-280000-00-00NoNoCurrent
51991-620-905199106209090 TABLET in 1 BOTTLE (51991-620-90) 90 tablet2023-04-01NoNoCurrent