Anastrozole

Product NDC
69117-0003
11-digit product format
691170003
Labeler code
69117
Product ID
69117-0003_4721ce01-03c8-f2d8-e063-6394a90ac3b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole Tablets
Dosage form
TABLET
Route
ORAL
Labeler
Yiling Pharmaceutical, Inc.
Application
ANDA206037
Marketing category
ANDA
Marketing start
2019-02-28
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
69117-0003-1Anastrozole30 in 1 BOTTLETABLET3012
69117-0003-4Anastrozole1000 in 1 BOTTLETABLET100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0003-1EA - Each69117-00036f368dd3-0e43-43e7-8d54-14f70bcc2edd12019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0003ANASTROZOLE (ANASTROZOLE TABLETS) TABLET [YILING PHARMACEUTICAL, INC.]11Current NDC, Legacy NDC, 2 package rows20241226_7b3da447-8e7c-2aaa-e053-2a91aa0a2821.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN7b3da447-8e7c-2aaa-e053-2a91aa0a282112
199224anastrozole 1 MG Oral TabletSCD7b3da447-8e7c-2aaa-e053-2a91aa0a282112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-0003-16911700030130 TABLET in 1 BOTTLE (69117-0003-1) 30 tablet2019-02-280000-00-00NoNoCurrent
69117-0003-4691170003041000 TABLET in 1 BOTTLE (69117-0003-4) 1000 tablet2019-02-280000-00-00NoNoCurrent