FDA.reportPublic FDA data

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

Additional Listing Data#

Finished product
Yes
Brand name base
SOLTAMOX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMOXIFEN CITRATE20 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7FRV7310N6
Rxcui389230, 644304

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3572c17-50b0-db2d-1012-2cc228ccf88fProduct name320201015
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-682-00SOLTAMOX150 mL in 1 CONTAINERLIQUID1502
51862-682-00SOLTAMOX1 in 1 CARTONLIQUID12
51862-682-01SOLTAMOX1 in 1 CARTONLIQUID12
51862-682-01SOLTAMOX150 mL in 1 CONTAINERLIQUID1502

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-682-01ML - Milliliter51862-682597b7e16-0271-4510-92a0-815c1a1736e212021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-682SOLTAMOX (TAMOXIFEN CITRATE) LIQUID [MAYNE PHARMA]2Current NDC, Legacy NDC, 4 package rows20211201_1e6ff055-590c-41e6-9530-1fdf04cdbd02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
644304SOLTAMOX 10 MG in 5 mL Oral SolutionPSN1e6ff055-590c-41e6-9530-1fdf04cdbd022
389230tamoxifen citrate 10 MG in 5 mL Oral SolutionPSN1e6ff055-590c-41e6-9530-1fdf04cdbd022
644304tamoxifen 2 MG/ML Oral Solution [Soltamox]SBD1e6ff055-590c-41e6-9530-1fdf04cdbd022
389230tamoxifen 2 MG/ML Oral SolutionSCD1e6ff055-590c-41e6-9530-1fdf04cdbd022
644304Soltamox 10 MG (as tamoxifen citrate 15.2 MG) per 5 ML Oral SolutionSY1e6ff055-590c-41e6-9530-1fdf04cdbd022
644304Soltamox 10 MG per 5 ML Oral SolutionSY1e6ff055-590c-41e6-9530-1fdf04cdbd022
644304Soltamox 2 MG/ML Oral SolutionSY1e6ff055-590c-41e6-9530-1fdf04cdbd022
389230tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) per 5 ML Oral SolutionSY1e6ff055-590c-41e6-9530-1fdf04cdbd022
389230tamoxifen 10 MG per 5 ML Oral SolutionSY1e6ff055-590c-41e6-9530-1fdf04cdbd022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51862-682-00518620682001 CONTAINER in 1 CARTON (51862-682-00) / 150 mL in 1 CONTAINER1 container2021-12-060000-00-00NoNoCurrent
51862-682-01518620682011 CONTAINER in 1 CARTON (51862-682-01) / 150 mL in 1 CONTAINER1 container2021-06-180000-00-00NoNoCurrent