Home NDC 62559-670 ARIMIDEX
Product NDC 62559-670
11-digit product format 625590670
Labeler code 62559
Product ID 62559-670_e8849657-0444-4ca8-bf66-2017f60d5652
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anastrozole
Dosage form TABLET
Route ORAL
Labeler ANI Pharmaceuticals, Inc.
Application NDA020541
Marketing category NDA
Marketing start 2018-06-26
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 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N020541-001 ARIMIDEX ANASTROZOLE 1MG TABLET / ORAL AB RLD, RS 1995-12-27
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020541-001 AB
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.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020541-001 ARIMIDEX 1MG TABLET / ORAL AB RLD, RS 1995-12-27 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base ARIMIDEX
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANASTROZOLE 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2Z07MYW1AZ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 151124 Internal RxNorm lookup 199224 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 62559-670-30 ARIMIDEX 30 in 1 BOTTLE TABLET 30 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62559-670 ARIMIDEX (ANASTROZOLE) TABLET [ANI PHARMACEUTICALS, INC.] 10 Current NDC, Legacy NDC, 1 package rows 20241222_acbfaaa9-503c-4691-9828-76a7146ed6de.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62559-670-30 62559067030 30 TABLET in 1 BOTTLE (62559-670-30) 30 tablet 2018-06-26 0000-00-00 No No Current