Home NDC 59651-516 Exemestane
Product NDC 59651-516
11-digit product format 596510516
Labeler code 59651
Product ID 59651-516_498de360-2fc1-4fcf-aa53-54eab01cba43
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Exemestane
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA216454
Marketing category ANDA
Marketing start 2022-05-20
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 A216454-001 EXEMESTANE EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A216454-001 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.
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 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 5c6f7cd8ea54…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216454-001 EXEMESTANE 25MG TABLET / ORAL AB 2022-05-20 a50c72e98297…
Observed Orange Book normalized TE history# 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 59651-516-30 Exemestane 30 in 1 BOTTLE TABLET, FILM COATED 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-516 EXEMESTANE TABLET, FILM COATED [AUROBINDO PHARMA LIMITED] 2 Current NDC, Legacy NDC, 1 package rows 20250501_e24b08eb-4693-41c7-81cb-b536947f7070.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 59651-516-30 59651051630 30 TABLET, FILM COATED in 1 BOTTLE (59651-516-30) 2022-05-20 0000-00-00 No No Current