Home NDC 64980-404 toremifene citrate
Product NDC 64980-404
11-digit product format 649800404
Labeler code 64980
Product ID 64980-404_6aa927e6-a0b9-4904-aa11-e5a3f52cee47
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name toremifene citrate
Dosage form TABLET
Route ORAL
Labeler Rising Pharma Holdings, Inc.
Application ANDA208813
Marketing category ANDA
Marketing start 2019-01-18
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 A208813-001 TOREMIFENE CITRATE TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A208813-001 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 · 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 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB RS 2018-12-04 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A208813-001 TOREMIFENE CITRATE EQ 60MG BASE TABLET / ORAL AB 2018-12-04 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base toremifene citrate
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 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 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 64980-404-03 toremifene citrate 30 in 1 BOTTLE, PLASTIC TABLET 30 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 64980-404 TOREMIFENE CITRATE TABLET [RISING PHARMA HOLDINGS, INC.] 3 Current NDC, Legacy NDC, 1 package rows 20250509_dbde10d5-c689-428f-841d-b34aa5addf2d.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.
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 64980-404-03 64980040403 30 TABLET in 1 BOTTLE, PLASTIC (64980-404-03) 30 tablet 2019-01-18 0000-00-00 No No Current