Tamoxifen Citrate

Product NDC
51862-642
11-digit product format
518620642
Labeler code
51862
Product ID
51862-642_c9174e2f-4862-4934-9837-4d0a16e74753
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mayne Pharma Inc.
Application
ANDA075797
Marketing category
ANDA
Marketing start
2021-08-27
Marketing end
0000-00-00
Substance
TAMOXIFEN CITRATE
Active strength
10 mg/1
Pharmacologic classes
Estrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c3572c17-50b0-db2d-1012-2cc228ccf88fProduct name320201015

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51862-642-10Tamoxifen Citrate1000 in 1 BOTTLETABLET, FILM COATED10005
51862-642-60Tamoxifen Citrate60 in 1 BOTTLETABLET, FILM COATED605

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-642-10EA - Each51862-642e01d66a6-0fab-4576-abc2-f9c92699ddbb12021-09-07
51862-642-60EA - Each51862-642acdacb43-7a5d-4549-b94f-01db4b53397812021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-642TAMOXIFEN CITRATE TABLET, FILM COATED [MAYNE PHARMA COMMERCIAL LLC]3Legacy NDC, 2 package rows20230224_c82205a3-ae0c-4ce5-b04b-9581cd8c70d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSNc82205a3-ae0c-4ce5-b04b-9581cd8c70d45
313195tamoxifen citrate 20 MG Oral TabletPSNc82205a3-ae0c-4ce5-b04b-9581cd8c70d45
198240tamoxifen 10 MG Oral TabletSCDc82205a3-ae0c-4ce5-b04b-9581cd8c70d45
313195tamoxifen 20 MG Oral TabletSCDc82205a3-ae0c-4ce5-b04b-9581cd8c70d45
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSYc82205a3-ae0c-4ce5-b04b-9581cd8c70d45
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSYc82205a3-ae0c-4ce5-b04b-9581cd8c70d45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
51862-642-10518620642101000 TABLET, FILM COATED in 1 BOTTLE (51862-642-10) 2021-08-270000-00-00NoNoCurrent
51862-642-605186206426060 TABLET, FILM COATED in 1 BOTTLE (51862-642-60) 2021-08-270000-00-00NoNoCurrent