Home NDC 80005-139 Letrozole
Product NDC 80005-139
11-digit product format 800050139
Labeler code 80005
Product ID 80005-139_9fb66539-2efe-47cc-9b78-85b096caac95
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Letrozole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Carnegie Pharmaceuticals LLC
Application ANDA091191
Marketing category ANDA
Marketing start 2026-06-30
Substance LETROZOLE
Active strength 2.5 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 43 .
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 A091191-001 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 A091191-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 84e616aacf4f…2026-08-18 06:07:40 2026-07 A091191-001 LETROZOLE 2.5MG TABLET / ORAL 2011-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A091191-001 LETROZOLE 2.5MG TABLET / ORAL 2011-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091191-001 LETROZOLE 2.5MG TABLET / ORAL 2011-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091191-001 LETROZOLE 2.5MG TABLET / ORAL 2011-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091191-001 LETROZOLE 2.5MG TABLET / ORAL 2011-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091191-001 LETROZOLE 2.5MG TABLET / ORAL 2011-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091191-001 LETROZOLE 2.5MG TABLET / ORAL 2011-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 f41ea6bd6efb…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Letrozole
Listing expiration 2027-12-31 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.
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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 80005-139-08 80005013908 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80005-139-08) 2026-06-30 No No Current 80005-139-10 80005013910 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80005-139-10) 2026-06-30 No No Current