Home NDC 51862-682 SOLTAMOX
Product NDC 51862-682
11-digit product format 518620682
Labeler code 51862
Product ID 51862-682_5bcbc281-342c-4b05-8409-53a08b1fc9f6
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name TAMOXIFEN CITRATE
Dosage form LIQUID
Route ORAL
Labeler Mayne Pharma
Application NDA021807
Marketing category NDA
Marketing start 2021-06-18
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 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 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…
Additional Listing Data#
Finished product Yes
Brand name base SOLTAMOX
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TAMOXIFEN CITRATE 20 mg/10mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7FRV7310N6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 389230 Internal RxNorm lookup 644304 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 51862-682-00 SOLTAMOX 150 mL in 1 CONTAINER LIQUID 150 2 51862-682-00 SOLTAMOX 1 in 1 CARTON LIQUID 1 2 51862-682-01 SOLTAMOX 1 in 1 CARTON LIQUID 1 2 51862-682-01 SOLTAMOX 150 mL in 1 CONTAINER LIQUID 150 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51862-682 SOLTAMOX (TAMOXIFEN CITRATE) LIQUID [MAYNE PHARMA] 2 Current NDC, Legacy NDC, 4 package rows 20211201_1e6ff055-590c-41e6-9530-1fdf04cdbd02.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 51862-682-00 51862068200 1 CONTAINER in 1 CARTON (51862-682-00) / 150 mL in 1 CONTAINER 1 container 2021-12-06 0000-00-00 No No Current 51862-682-01 51862068201 1 CONTAINER in 1 CARTON (51862-682-01) / 150 mL in 1 CONTAINER 1 container 2021-06-18 0000-00-00 No No Current