Home NDC 51991-759 LETROZOLE
Product NDC 51991-759
11-digit product format 519910759
Labeler code 51991
Product ID 51991-759_35b275df-f687-4e29-828b-637d5377cc73
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name LETROZOLE
Dosage form TABLET
Route ORAL
Labeler Breckenridge Pharmaceutical, Inc.
Application ANDA200161
Marketing category ANDA
Marketing start 2011-06-04
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 A200161-001 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 A200161-001 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 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200161-001 LETROZOLE 2.5MG TABLET / ORAL AB 2011-06-03 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200161-001 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 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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51991-759-10 LETROZOLE 1000 in 1 BOTTLE TABLET 1000 11 51991-759-33 LETROZOLE 30 in 1 BOTTLE TABLET 30 11 51991-759-90 LETROZOLE 90 in 1 BOTTLE TABLET 90 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LETROZOLE ACTIVE INGREDIENT 7LKK855W8I LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 LETROZOLE ACTIVE MOIETY 7LKK855W8I LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 HYPROMELLOSE 2910 (6 MPA.S) INACTIVE INGREDIENT 0WZ8WG20P6 LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 TALC INACTIVE INGREDIENT 7SEV7J4R1U LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51991-759 LETROZOLE TABLET [BRECKENRIDGE PHARMACEUTICAL, INC.] 11 Current NDC, Legacy NDC, 3 package rows 20240327_63e54b62-a30d-4a56-9215-75e7a0b0bf02.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 · 5 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 51991-759-10 51991075910 1000 TABLET in 1 BOTTLE (51991-759-10) 1000 tablet 2011-06-04 0000-00-00 No No Current 51991-759-33 51991075933 30 TABLET in 1 BOTTLE (51991-759-33) 30 tablet 2011-06-04 0000-00-00 No No Current 51991-759-90 51991075990 90 TABLET in 1 BOTTLE (51991-759-90) 90 tablet 2022-10-01 0000-00-00 No No Current