Home NDC 42747-327 Fareston
Product NDC 42747-327
11-digit product format 427470327
Labeler code 42747
Product ID 42747-327_11857fbe-6c5e-485e-b5d4-7f091a331928
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name toremifene citrate
Dosage form TABLET
Route ORAL
Labeler Kyowa Kirin, Inc.
Application NDA020497
Marketing category NDA
Marketing start 1997-06-30
Substance TOREMIFENE CITRATE
Active strength 60 mg/1
Pharmacologic classes Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [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 1 .
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 N020497-001 FARESTON TOREMIFENE CITRATE EQ 60MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 1997-05-29
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 · 41 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 2026-02-19 14:30 UTC 2026-02 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL RLD 1997-05-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N020497-001 FARESTON EQ 60MG BASE TABLET / ORAL AB RLD, RS 1997-05-29 cb3db0bc1861…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Fareston
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TOREMIFENE CITRATE 60 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2498Y783QT Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 152880 Internal RxNorm lookup 313428 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 42747-327-30 Fareston 30 in 1 BOTTLE TABLET 30 11 42747-327-72 Fareston 7 in 1 BLISTER PACK TABLET 7 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded TOREMIFENE CITRATE ACTIVE INGREDIENT 2498Y783QT FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 TOREMIFENE ACTIVE MOIETY 7NFE54O27T FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 POVIDONE INACTIVE INGREDIENT FZ989GH94E FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ FARESTON (TOREMIFENE CITRATE) TABLET [PROSTRAKAN, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42747-327 FARESTON (TOREMIFENE CITRATE) TABLET [KYOWA KIRIN, INC.] 11 Current NDC, Legacy NDC, 2 package rows 20241115_2cab8dd1-3a10-48e6-86ce-0e5275ed49e5.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 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Fareston TOREMIFENE CITRATE Kyowa Kirin, Inc. 2cab8dd1-3a10-48e6-86ce-0e5275ed49e5 2024-11-13 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 020497 application number: NDA020497 ndc (product): 42747-327
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 42747-327-30 42747032730 30 TABLET in 1 BOTTLE (42747-327-30) 30 tablet 1997-06-30 0000-00-00 No No Current 42747-327-72 42747032772 7 TABLET in 1 BLISTER PACK (42747-327-72) 7 tablet 1997-06-30 0000-00-00 No No Current