Home NDC 59762-2858 EXEMESTANE
Product NDC 59762-2858
11-digit product format 597622858
Labeler code 59762
Product ID 59762-2858_6aeb23c4-3f3f-4966-829c-12e7e6ec91ef
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Exemestane
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA020753
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2011-04-01
Substance EXEMESTANE
Active strength 25 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 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 N020753-001 AROMASIN EXEMESTANE 25MG TABLET / ORAL AB RLD, RS 1999-10-21
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code N020753-001 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 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020753-001 AROMASIN 25MG TABLET / ORAL AB RLD, RS 1999-10-21 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 EXEMESTANE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength EXEMESTANE 25 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination NY22HMQ4BX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 310261 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 59762-2858-1 EXEMESTANE 30 in 1 BOTTLE TABLET, SUGAR COATED 30 20
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded EXEMESTANE ACTIVE INGREDIENT NY22HMQ4BX EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 EXEMESTANE ACTIVE MOIETY NY22HMQ4BX EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 MAGNESIUM CARBONATE INACTIVE INGREDIENT 0E53J927NA EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 MANNITOL INACTIVE INGREDIENT 3OWL53L36A EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 POLYVINYL ALCOHOL INACTIVE INGREDIENT 532B59J990 EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 SUCROSE INACTIVE INGREDIENT C151H8M554 EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP EXEMESTANE TABLET, SUGAR COATED [GREENSTONE LLC] 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59762-2858 EXEMESTANE TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.] 19 Current NDC, Legacy NDC, 1 package rows 20250522_69abd0ff-b200-4d1a-b14a-80e980a8e781.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59762-2858-1 59762285801 30 TABLET, SUGAR COATED in 1 BOTTLE (59762-2858-1) 2011-04-01 0000-00-00 No No Current