FDA.reportPublic FDA data

Anastrozole

Product NDC
68071-5203
11-digit product format
680715203
Labeler code
68071
Product ID
68071-5203_1b56dc79-b02a-5fa2-e063-6394a90a9498
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
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
68071-5203-32022-02-07C16284748780-1d6a99b39-d4a4-a426-e053-dadaa90af4c2These 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
68071-5203-32022-01-28C16284748780-1d6a99b39-d4a4-a426-e053-dadaa90af4c2These 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
68071-5203-3Anastrozole30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5203ANASTROZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240622_a0acddf1-a973-bf37-e053-2995a90a0bd5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSNa0acddf1-a973-bf37-e053-2995a90a0bd53
199224anastrozole 1 MG Oral TabletSCDa0acddf1-a973-bf37-e053-2995a90a0bd53

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-5203-36807152030330 TABLET in 1 BOTTLE (68071-5203-3) 30 tablet2020-03-120000-00-00NoNoCurrent