FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
ANASTROZOLE
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANASTROZOLE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2Z07MYW1AZ
Rxcui199224

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

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 tablet2023-04-01NoNoHistorical