FDA.reportPublic FDA data

Anastrozole

Product NDC
50090-2453
11-digit product format
500902453
Labeler code
50090
Product ID
50090-2453_ea40c7f6-80fd-4863-abf0-a5c4d64e4a81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA090568
Marketing category
ANDA
Marketing start
2010-06-22
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-2453-02023-02-07C16284748780-1f386c64a-487b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
50090-2453-12023-02-07C16284748780-1f386c64a-487b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
50090-2453-02023-01-30C16284748780-1f386c64a-487b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
50090-2453-12023-01-30C16284748780-1f386c64a-487b-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-2453-0Anastrozole30 in 1 BOTTLE, PLASTICTABLET3020
50090-2453-1Anastrozole90 in 1 BOTTLE, PLASTICTABLET9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-2453-0EA - Each50090-245390c978b6-f320-47d0-9535-571b28af816c12019-03-12
50090-2453-1EA - Each50090-24539b52489a-f584-4bf5-8dc5-d7e5bd31738612021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-2453ANASTROZOLE TABLET [A-S MEDICATION SOLUTIONS]20Current NDC, Legacy NDC, 2 package rows20240606_03fb3108-1856-466d-bf88-0eac96139551.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN03fb3108-1856-466d-bf88-0eac9613955120
199224anastrozole 1 MG Oral TabletSCD03fb3108-1856-466d-bf88-0eac9613955120

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-2453-05009024530030 TABLET in 1 BOTTLE, PLASTIC (50090-2453-0) 30 tablet2016-08-110000-00-00NoNoCurrent
50090-2453-15009024530190 TABLET in 1 BOTTLE, PLASTIC (50090-2453-1) 90 tablet2018-06-120000-00-00NoNoCurrent