FDA.reportPublic FDA data

Anastrozole

Product NDC
68001-155
11-digit product format
680010155
Labeler code
68001
Product ID
68001-155_2dc9d4ae-4fbc-df45-e063-6394a90a09a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET, COATED
Route
ORAL
Labeler
BluePoint Laboratories
Application
ANDA078921
Marketing category
ANDA
Marketing start
2014-01-01
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A078921-001ANASTROZOLEANASTROZOLE1MGTABLET / ORALAB2010-06-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A078921-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A078921-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A078921-001AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnastrozoleANASTROZOLEBryant Ranch Prepackf5b53383-0366-4ae2-9aa4-88b56c0bbd072026-06-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
AnastrozoleANASTROZOLEAmerican Health Packagingdface914-5135-4136-82f4-75429b496a352025-08-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.b023a9f2-1a99-4b40-a953-edac7e3a79bf2025-02-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
AnastrozoleANASTROZOLEBluePoint Laboratories3cd04ed6-7c5a-4c4a-9955-ee40839dfea02025-02-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
ndc (product): 68001-155
AnastrozoleANASTROZOLEZydus Pharmaceuticals USA Inc.ca16f8de-d9a5-4c6c-957b-ae28497b67ac2025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 078921
application number: ANDA078921
AnastrozoleANASTROZOLEZydus Lifesciences Limited965c4cb1-f6b8-47ac-bf13-c36639aa908f2024-11-25Exact identifier
application applno (ANDA): 078921
application number: ANDA078921

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2Z07MYW1AZInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
199224Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3cd04ed6-7c5a-4c4a-9955-ee40839dfea0Available on FDA.report

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
68001-155-04Anastrozole30 in 1 BOTTLETABLET, COATED3010
68001-155-08Anastrozole1000 in 1 BOTTLETABLET, COATED100010

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]3
ANASTROZOLEACTIVE INGREDIENT2Z07MYW1AZANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
ANASTROZOLEACTIVE MOIETY2Z07MYW1AZANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPANASTROZOLE TABLET, COATED [AMERICAN HEALTH PACKAGING]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-155ANASTROZOLE TABLET, COATED [BLUEPOINT LABORATORIES]10Current NDC, Legacy NDC, 2 package rows20250212_3cd04ed6-7c5a-4c4a-9955-ee40839dfea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSN3cd04ed6-7c5a-4c4a-9955-ee40839dfea010
199224anastrozole 1 MG Oral TabletSCD3cd04ed6-7c5a-4c4a-9955-ee40839dfea010
199224anastrozole 1 MG Oral TabletPSNdface914-5135-4136-82f4-75429b496a358
199224anastrozole 1 MG Oral TabletSCDdface914-5135-4136-82f4-75429b496a358

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68001-155-046800101550430 TABLET, COATED in 1 BOTTLE (68001-155-04) 2014-01-010000-00-00NoNoCurrent
68001-155-08680010155081000 TABLET, COATED in 1 BOTTLE (68001-155-08) 2014-01-010000-00-00NoNoCurrent