Anastrozole

Product NDC
68382-209
11-digit product format
683820209
Labeler code
68382
Product ID
68382-209_577b7171-5da0-4291-af07-5e4653ffb3aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
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
68382-209-06Anastrozole30 in 1 BOTTLETABLET, COATED3015
68382-209-10Anastrozole1000 in 1 BOTTLETABLET, COATED100015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-209-06EA - Each68382-209543bd8c9-1460-4681-94c5-54b11008987f12012-07-24
68382-209-10EA - Each68382-20943bb9e76-1caf-47e7-92fe-419b4b4a578f12012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-209ANASTROZOLE TABLET, COATED [ZYDUS PHARMACEUTICALS USA INC.]15Current NDC, Legacy NDC, 2 package rows20250108_ca16f8de-d9a5-4c6c-957b-ae28497b67ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSNb023a9f2-1a99-4b40-a953-edac7e3a79bf16
199224anastrozole 1 MG Oral TabletSCDb023a9f2-1a99-4b40-a953-edac7e3a79bf16
199224anastrozole 1 MG Oral TabletPSNca16f8de-d9a5-4c6c-957b-ae28497b67ac15
199224anastrozole 1 MG Oral TabletSCDca16f8de-d9a5-4c6c-957b-ae28497b67ac15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68382-209-066838202090630 TABLET, COATED in 1 BOTTLE (68382-209-06) 2010-06-270000-00-00NoNoCurrent
68382-209-10683820209101000 TABLET, COATED in 1 BOTTLE (68382-209-10) 2010-06-270000-00-00NoNoCurrent