Home NDC 71205-587 Letrozole
Product NDC 71205-587
11-digit product format 712050587
Labeler code 71205
Product ID 71205-587_e1390a0d-0280-49a5-a2d4-d2e13e9952ca
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Letrozole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA090289
Marketing category ANDA
Marketing start 2011-06-03
Substance LETROZOLE
Active strength 2.5 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 A090289-001 LETROZOLE LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A090289-001 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 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A090289-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 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 Letrozole
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LETROZOLE 2.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7LKK855W8I Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 200064 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 71205-587-30 Letrozole 30 in 1 BOTTLE TABLET, FILM COATED 30 1 71205-587-60 Letrozole 60 in 1 BOTTLE TABLET, FILM COATED 60 1 71205-587-90 Letrozole 90 in 1 BOTTLE TABLET, FILM COATED 90 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71205-587 LETROZOLE TABLET, FILM COATED [PROFICIENT RX LP] 1 Current NDC, Legacy NDC, 3 package rows 20210713_e1390a0d-0280-49a5-a2d4-d2e13e9952ca.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 · 3 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 71205-587-30 71205058730 30 TABLET, FILM COATED in 1 BOTTLE (71205-587-30) 2021-07-07 0000-00-00 No No Current 71205-587-60 71205058760 60 TABLET, FILM COATED in 1 BOTTLE (71205-587-60) 2021-07-07 0000-00-00 No No Current 71205-587-90 71205058790 90 TABLET, FILM COATED in 1 BOTTLE (71205-587-90) 2021-07-07 0000-00-00 No No Current