Home NDC 0310-0201-90 ARIMIDEX
Product NDC 0310-0201
Requested package NDC 0310-0201-90
11-digit product format 003100201
Labeler code 0310
Product ID 0310-0201_a11a1b6f-a483-457d-92c2-6140f6b2d83e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Anastrozole
Dosage form TABLET
Route ORAL
Labeler AstraZeneca Pharmaceuticals LP
Application NDA020541
Marketing category NDA
Marketing start 1996-01-16
Marketing end 2019-06-30
Substance ANASTROZOLE
Active strength 1 mg/1
Pharmacologic classes Aromatase Inhibitor [EPC],Aromatase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 21 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 21:27 UTC · source 2025-12-05 a6255e0c9aa5…a0211a219f2e…2025-08-26 23:59 UTC · source 2025-08-26 1d862106b807…00c93037cd84…2025-05-15 14:59 UTC · source 2025-05-14 390b4c401c3f…2c692c2daee3…2025-04-01 07:37 UTC · source 2025-03-31 e30019b0c005…a3f0b14938b7…2025-03-01 13:19 UTC · source 2025-02-28 bbbc9f937eca…946b9c97cf81…2025-02-27 05:24 UTC · source 2025-02-26 f268b84574a6…26285f5ac5df…2025-02-01 13:13 UTC · source 2025-01-31 f764e8902f78…92046438deef…2025-01-20 13:05 UTC · source 2025-01-17 68b1e3bced9e…98a755eb8bc6…2024-11-29 20:42 UTC · source 2024-11-29 05c55d027831…ca05dca9dc4c…2024-11-09 02:36 UTC · source 2024-11-08 48b4f40e6753…c7c7a00d2afa…2024-10-09 02:27 UTC · source 2024-10-08 27f29a85d7e4…1372111e901f…2024-07-10 04:00 UTC · source 2024-07-09 8d62ce987f31…9fe9ef23e30d…2024-05-28 21:11 UTC · source 2024-05-28 d1e113ab4d42…063ee3eb0a1d…2024-05-15 03:51 UTC · source 2024-05-14 50b4072663b7…eae3003ed65e…2022-04-09 23:13 UTC · source 2022-04-08 906f6e251498…bf70b80e44f0…2021-12-27 23:28 UTC · source 2021-12-27 6db9cb8d1e19…3449e1ec5b70…2021-02-18 23:40 UTC · source 2021-02-18 8fc7167e32ce…e96bbc724034…2020-12-18 03:04 UTC · source 2020-12-17 4184dd79f89f…545327b3e20f…2020-06-10 20:45 UTC · source 2020-06-10 4bd3596a7b87…5c64c6f6865f…2019-12-08 06:16 UTC · source 2019-12-05 263afe128892…91768de4ddbe…2019-06-01 22:24 UTC · source 2019-05-30 5b2001dcd8f5…54b53d4dc9e4…
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 No
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ANASTROZOLE 1 mg/1
DailyMed Product Concepts# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 POLYETHYLENE GLYCOLS INACTIVE INGREDIENT 3WJQ0SDW1A ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 POVIDONES INACTIVE INGREDIENT FZ989GH94E ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ARIMIDEX (ANASTROZOLE) TABLET [ASTRAZENECA PHARMACEUTICALS LP] 14 ANASTROZOLE ACTIVE INGREDIENT 2Z07MYW1AZ ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 ANASTROZOLE ACTIVE MOIETY 2Z07MYW1AZ ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 LACTOSE INACTIVE INGREDIENT J2B2A4N98G ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POLYETHYLENE GLYCOL INACTIVE INGREDIENT 3WJQ0SDW1A ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 POVIDONE INACTIVE INGREDIENT FZ989GH94E ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ARIMIDEX (ANASTROZOLE) TABLET [PHYSICIANS TOTAL CARE, INC.] 2
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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ARIMIDEX ANASTROZOLE ANI Pharmaceuticals, Inc. acbfaaa9-503c-4691-9828-76a7146ed6de 2026-03-02 Warnings, Adverse reactions Exact identifier application applno (NDA): 020541 application number: NDA020541
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Status 0310-0201-90 00310020190 90000 TABLET in 1 DRUM (0310-0201-90) 90000 tablet 03-APR-19 Current