Home NDC 89141-123 Soltamox
Product NDC 89141-123
11-digit product format 891410123
Labeler code 89141
Product ID 89141-123_0e8ed8c2-2f89-4585-88b3-de75c37be094
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TAMOXIFEN CITRATE
Dosage form LIQUID
Route ORAL
Labeler Fortovia Therapeutics Inc.
Application NDA021807
Marketing category NDA
Marketing start 2005-10-29
Marketing end 2022-06-30
Substance TAMOXIFEN CITRATE
Active strength 20 mg/10mL
Pharmacologic classes Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag No
Listing certified through 0000-00-00
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 89141-123-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 89141-123-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 89141-123-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 89141-123-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 89141-123-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 89141-123-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 89141-123-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 89141-123-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 89141-123-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 89141-123-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 89141-123-01 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 excluded product product 557ba5c1ecfa…9c80585c8c6e…2024-07-10 04:00 UTC · source 2024-07-09 excluded package package 89141-123-01 557ba5c1ecfa…9c80585c8c6e…
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 N021807-001 SOLTAMOX TAMOXIFEN CITRATE EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29
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 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL 2005-10-29 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL 2005-10-29 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL 2005-10-29 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL 2005-10-29 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL 2005-10-29 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 N021807-001 SOLTAMOX EQ 20MG BASE/10ML SOLUTION / ORAL RLD, RS 2005-10-29 cb3db0bc1861…
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 SOLTAMOX TAMOXIFEN CITRATE Mayne Pharma 1e6ff055-590c-41e6-9530-1fdf04cdbd02 2021-11-29 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021807 application number: NDA021807
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 89141-123-01 89141012301 1 CONTAINER in 1 CARTON (89141-123-01) > 150 mL in 1 CONTAINER 1 container 2018-02-28 2022-06-30 No No Current