FDA.reportPublic FDA data

Anastrozole

Product NDC
42291-085
11-digit product format
422910085
Labeler code
42291
Product ID
42291-085_485b734b-5e6d-f952-e063-6394a90a3aff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
AvKARE
Application
ANDA078058
Marketing category
ANDA
Marketing start
2020-03-13
Substance
ANASTROZOLE
Active strength
1 mg/1
Pharmacologic classes
Aromatase Inhibitor [EPC], Aromatase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Anastrozole
Listing expiration
2027-12-31

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
42291-085-30Anastrozole30 in 1 BOTTLETABLET, FILM COATED306
42291-085-90Anastrozole90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42291-085-30EA - Each42291-0852dfb64b6-cb55-4b00-b016-952d7a7e707a12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42291-085ANASTROZOLE TABLET, FILM COATED [AVKARE]5Current NDC, Legacy NDC, 2 package rows20240110_a0c2672b-e07b-4f6c-e053-2a95a90a2e5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSNa0c2672b-e07b-4f6c-e053-2a95a90a2e5d6
199224anastrozole 1 MG Oral TabletSCDa0c2672b-e07b-4f6c-e053-2a95a90a2e5d6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42291-085-304229100853030 TABLET, FILM COATED in 1 BOTTLE (42291-085-30) 2020-03-130000-00-00NoNoCurrent
42291-085-904229100859090 TABLET, FILM COATED in 1 BOTTLE (42291-085-90) 2020-09-230000-00-00NoNoCurrent