FDA.reportPublic FDA data

Tamoxifen Citrate

Product NDC
51862-643
11-digit product format
518620643
Labeler code
51862
Product ID
51862-643_433f16e8-7df7-8a6e-e063-6394a90a7c4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mayne Pharma Commercial LLC
Application
ANDA075797
Marketing category
ANDA
Marketing start
2021-08-27
Substance
TAMOXIFEN CITRATE
Active strength
20 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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TAMOXIFEN CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7FRV7310N6
Rxcui198240, 313195

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
51862-643-10Tamoxifen Citrate1000 in 1 BOTTLETABLET, FILM COATED10005
51862-643-30Tamoxifen Citrate30 in 1 BOTTLETABLET, FILM COATED305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51862-643-10EA - Each51862-6435c19f66f-42f1-4fda-b320-ed97ea3debff12021-09-07
51862-643-30EA - Each51862-6430542b081-740d-42f1-888d-76414f355a2512021-09-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51862-643TAMOXIFEN CITRATE TABLET, FILM COATED [MAYNE PHARMA COMMERCIAL LLC]3Current NDC, Legacy 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
51862-643-10518620643101000 TABLET, FILM COATED in 1 BOTTLE (51862-643-10) 2021-08-270000-00-00NoNoCurrent
51862-643-305186206433030 TABLET, FILM COATED in 1 BOTTLE (51862-643-30) 2021-08-270000-00-00NoNoCurrent