Anastrozole

Product NDC
63850-0010
11-digit product format
638500010
Labeler code
63850
Product ID
63850-0010_605b2a4c-1f1d-473d-a911-133ca46f0538
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
Natco Pharma Limited
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
63850-0010-1Anastrozole30 in 1 BOTTLETABLET306
63850-0010-2Anastrozole1000 in 1 BOTTLETABLET10006

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63850-0010ANASTROZOLE TABLET [NATCO PHARMA LIMITED]6Current NDC, Legacy NDC, 2 package rows20201020_df55dc4c-9a53-4a37-a90f-c4e88d458b89.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSNdf55dc4c-9a53-4a37-a90f-c4e88d458b896
199224anastrozole 1 MG Oral TabletSCDdf55dc4c-9a53-4a37-a90f-c4e88d458b896

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63850-0010-16385000100130 TABLET in 1 BOTTLE (63850-0010-1) 30 tablet2010-06-280000-00-00NoNoCurrent
63850-0010-2638500010021000 TABLET in 1 BOTTLE (63850-0010-2) 1000 tablet2010-06-280000-00-00NoNoCurrent