Home NDC 55111-646 Letrozole
Product NDC 55111-646
11-digit product format 551110646
Labeler code 55111
Product ID 55111-646_ec1b249b-2d77-55d9-0520-23884a961cf0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Letrozole
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Dr. Reddy's Laboratories Limited
Application ANDA091191
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 A091191-001 LETROZOLE LETROZOLE 2.5MG TABLET / ORAL 2011-06-03
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 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…2022-09-29 23:25 UTC 2022-09 A091191-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 e64feba35796…
Observed Orange Book normalized TE history# 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 55111-646-30 Letrozole 30 in 1 BOTTLE TABLET, FILM COATED 30 6 55111-646-78 Letrozole 10 in 1 CARTON TABLET, FILM COATED 10 6 55111-646-79 Letrozole 10 in 1 BLISTER PACK TABLET, FILM COATED 10 6
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Letrozole ACTIVE INGREDIENT 7LKK855W8I LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 letrozole ACTIVE MOIETY 7LKK855W8I LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 colloidal silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 lactose monohydrate INACTIVE INGREDIENT EWQ57Q8I5X LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 magnesium stearate INACTIVE INGREDIENT 70097M6I30 LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 polyethylene glycol INACTIVE INGREDIENT 3WJQ0SDW1A LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 povidone INACTIVE INGREDIENT FZ989GH94E LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 talc INACTIVE INGREDIENT 7SEV7J4R1U LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55111-646 LETROZOLE TABLET, FILM COATED [DR. REDDY'S LABORATORIES LIMITED] 6 Current NDC, Legacy NDC, 3 package rows 20181207_6cfd29d7-f519-7b8c-4814-07b39f367f0d.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 Units Marketing start Marketing end Sample Exclude flag Status 55111-646-30 55111064630 30 TABLET, FILM COATED in 1 BOTTLE (55111-646-30) 2011-06-03 0000-00-00 No No Current 55111-646-78 55111064678 10 BLISTER PACK in 1 CARTON (55111-646-78) / 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-646-79) 10 blister pack 2011-06-03 0000-00-00 No No Current 55111-646-79 55111064679 10 in 1 BLISTER PACK Historical