FDA.reportPublic FDA data

Anastrozole

Product NDC
68071-2791
11-digit product format
680712791
Labeler code
68071
Product ID
68071-2791_31e27616-7902-a78b-e063-6394a90a5f5a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA090568
Marketing category
ANDA
Marketing start
2010-06-22
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2791-22025-03-17C16284748780-12cef2736-6217-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
68071-2791-52025-03-17C16284748780-12cef2736-6217-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
68071-2791-82025-03-17C16284748780-12cef2736-6217-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
68071-2791-22025-01-30C16284748780-12cef2736-6217-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
68071-2791-52025-01-30C16284748780-12cef2736-6217-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995
68071-2791-82025-01-30C16284748780-12cef2736-6217-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use ANASTROZOLE TABLETS safely and effectively. See full prescribing information for ANASTROZOLE TABLETS. ANASTROZOLE tablet, for oral use. Initial U.S. Approval: 1995

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2791-0Anastrozole8 in 1 BOTTLE, PLASTICTABLET85
68071-2791-2Anastrozole20 in 1 BOTTLE, PLASTICTABLET205
68071-2791-5Anastrozole15 in 1 BOTTLE, PLASTICTABLET155
68071-2791-7Anastrozole12 in 1 BOTTLE, PLASTICTABLET125
68071-2791-8Anastrozole180 in 1 BOTTLE, PLASTICTABLET1805

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2791ANASTROZOLE TABLET [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 5 package rows20250406_e3b5fc92-9189-6944-e053-2a95a90a1c9f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSNe3b5fc92-9189-6944-e053-2a95a90a1c9f5
199224anastrozole 1 MG Oral TabletSCDe3b5fc92-9189-6944-e053-2a95a90a1c9f5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2791-0680712791008 TABLET in 1 BOTTLE, PLASTIC (68071-2791-0) 8 tablet2025-03-17NoNoCurrent
68071-2791-26807127910220 TABLET in 1 BOTTLE, PLASTIC (68071-2791-2) 20 tablet2022-07-13NoNoCurrent
68071-2791-56807127910515 TABLET in 1 BOTTLE, PLASTIC (68071-2791-5) 15 tablet2022-07-130000-00-00NoNoCurrent
68071-2791-76807127910712 TABLET in 1 BOTTLE, PLASTIC (68071-2791-7) 12 tablet2025-01-03NoNoCurrent
68071-2791-868071279108180 TABLET in 1 BOTTLE, PLASTIC (68071-2791-8) 180 tablet2022-07-13NoNoCurrent