FDA.reportPublic FDA data

Anastrozole

Product NDC
76420-004
Requested package NDC
76420-004-20
11-digit product format
764200004
Labeler code
76420
Product ID
76420-004_4ad5b64f-c4f3-4aa0-e063-6394a90a8a21
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Anastrozole
Dosage form
TABLET
Route
ORAL
Labeler
Asclemed USA, 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
2027-12-31
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
A090568-001ANASTROZOLEANASTROZOLE1MGTABLET / 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
A090568-001AB

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 22:54:322026-06A090568-001ANASTROZOLE1MGTABLET / ORALAB2010-06-28a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A090568-001AB1a50c72e98297…

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 · 11 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AnastrozoleANASTROZOLEPD-Rx Pharmaceuticals, Inc.aabd8f88-2b52-4d43-8dc6-61605988c4dc2026-07-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEAsclemed USA, Inc.b964f555-25d2-47ad-8942-f195f062445c2026-02-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
ndc (package): 76420-004-20
ndc (product): 76420-004
ndc11 (package): 76420000420
AnastrozoleANASTROZOLEAccord Healthcare Inc.03586c40-eb32-45c5-beb7-6762a6b787902026-02-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.e3b5fc92-9189-6944-e053-2a95a90a1c9f2025-04-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
ANASTROZOLEANASTROZOLEDirect_Rxf37db328-bb81-9df9-e053-2a95a90a6f432025-01-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.5a2d5052-95ce-d103-e053-2991aa0aa4be2024-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEBryant Ranch Prepack19251d0b-279a-49f5-99b2-0e74d7cca4792024-08-22Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.a0acddf1-a973-bf37-e053-2995a90a0bd52024-06-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEA-S Medication Solutions03fb3108-1856-466d-bf88-0eac961395512024-06-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLENuCare Pharmaceuticals,Inc.ef6c9f7c-a1b0-3fee-e053-2995a90ab2c42024-04-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568
AnastrozoleANASTROZOLEProficient Rx LPc7a36fd8-530e-4c63-97d5-0f80fab5880e2023-05-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 090568
application number: ANDA090568

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 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
b964f555-25d2-47ad-8942-f195f062445cAvailable 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
76420-004-12Anastrozole120 in 1 BOTTLE, PLASTICTABLET1203
76420-004-15Anastrozole150 in 1 BOTTLE, PLASTICTABLET1503
76420-004-20Anastrozole20 in 1 BOTTLE, PLASTICTABLET203
76420-004-30Anastrozole30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-004ANASTROZOLE TABLET [ASCLEMED USA, INC.]2Current NDC, Legacy NDC, 4 package rows20221013_b964f555-25d2-47ad-8942-f195f062445c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
199224anastrozole 1 MG Oral TabletPSNb964f555-25d2-47ad-8942-f195f062445c3
199224anastrozole 1 MG Oral TabletSCDb964f555-25d2-47ad-8942-f195f062445c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76420-004-207642000042020 TABLET in 1 BOTTLE, PLASTIC (76420-004-20) 20 tablet2019-12-240000-00-00NoNoCurrent