FDA.reportPublic FDA data

Anastrozole

Product NDC
63187-080
11-digit product format
631870080
Labeler code
63187
Product ID
63187-080_67be1aec-dfea-48ba-927a-162e4c2e9107
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA090568
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
63187-080-18Anastrozole18 in 1 BOTTLE, PLASTICTABLET187
63187-080-20Anastrozole20 in 1 BOTTLE, PLASTICTABLET207
63187-080-30Anastrozole30 in 1 BOTTLE, PLASTICTABLET307
63187-080-60Anastrozole60 in 1 BOTTLE, PLASTICTABLET607
63187-080-90Anastrozole90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-080-18EA - Each63187-080e32aa7b1-c0f5-4268-a134-e988d1d2a0c312022-08-04
63187-080-20EA - Each63187-08095d7108b-5cea-40b7-a80b-cc603ffeab1412023-08-08
63187-080-90EA - Each63187-080e2db3027-7cb7-418a-b90c-1d5e995a170d12023-08-08

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET [PROFICIENT RX LP]1
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET [PROFICIENT RX LP]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4ANASTROZOLE TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XANASTROZOLE TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET [PROFICIENT RX LP]1
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQANASTROZOLE TABLET [PROFICIENT RX LP]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET [PROFICIENT RX LP]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET [PROFICIENT RX LP]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-080ANASTROZOLE TABLET [PROFICIENT RX LP]7Current NDC, Legacy NDC, 5 package rows20230506_c7a36fd8-530e-4c63-97d5-0f80fab5880e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSNc7a36fd8-530e-4c63-97d5-0f80fab5880e7
199224anastrozole 1 MG Oral TabletSCDc7a36fd8-530e-4c63-97d5-0f80fab5880e7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-080-186318700801818 TABLET in 1 BOTTLE, PLASTIC (63187-080-18) 18 tablet2022-03-250000-00-00NoNoCurrent
63187-080-206318700802020 TABLET in 1 BOTTLE, PLASTIC (63187-080-20) 20 tablet2023-05-02NoNoHistorical
63187-080-306318700803030 TABLET in 1 BOTTLE, PLASTIC (63187-080-30) 30 tablet2018-11-010000-00-00NoNoCurrent
63187-080-606318700806060 TABLET in 1 BOTTLE, PLASTIC (63187-080-60) 60 tablet2022-03-250000-00-00NoNoCurrent
63187-080-906318700809090 TABLET in 1 BOTTLE, PLASTIC (63187-080-90) 90 tablet2022-03-250000-00-00NoNoCurrent