FDA.reportPublic FDA data

Anastrozole

Product NDC
65841-743
11-digit product format
658410743
Labeler code
65841
Product ID
65841-743_756f0274-e970-4317-92c0-f5005b5bf9f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA078921
Marketing category
ANDA
Marketing start
2010-06-27
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
65841-743-06Anastrozole30 in 1 BOTTLETABLET, COATED309
65841-743-10Anastrozole1000 in 1 BOTTLETABLET, COATED10009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
POVIDONEINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET, COATED [CADILA HEALTHCARE LIMITED]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-743ANASTROZOLE TABLET, COATED [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 2 package rows20241127_965c4cb1-f6b8-47ac-bf13-c36639aa908f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN965c4cb1-f6b8-47ac-bf13-c36639aa908f9
199224anastrozole 1 MG Oral TabletSCD965c4cb1-f6b8-47ac-bf13-c36639aa908f9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65841-743-066584107430630 TABLET, COATED in 1 BOTTLE (65841-743-06) 2010-06-270000-00-00NoNoCurrent
65841-743-10658410743101000 TABLET, COATED in 1 BOTTLE (65841-743-10) 2010-06-270000-00-00NoNoCurrent