Tamoxifen Citrate

Product NDC
0378-0144
11-digit product format
003780144
Labeler code
0378
Product ID
0378-0144_2c1fe025-1eb2-4b2f-b8c9-5d0cfc3c683e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA074732
Marketing category
ANDA
Marketing start
2003-02-20
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
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 CITRATE10 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
0378-0144-91Tamoxifen Citrate60 in 1 BOTTLETABLET6013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0144-05EA - Each0378-0144c2aeb54c-8587-49c3-96b9-ad540ddd41bc12012-07-24
0378-0144-91EA - Each0378-0144e66febfe-a8e8-45ef-bee7-a5d177775aa712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMOXIFEN CITRATEACTIVE INGREDIENT7FRV7310N6TAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5
TAMOXIFENACTIVE MOIETY094ZI81Y45TAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5
CROSPOVIDONEINACTIVE INGREDIENT68401960MKTAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-0144TAMOXIFEN CITRATE TABLET [MYLAN PHARMACEUTICALS INC.]11Current NDC, Legacy NDC, 1 package rows20230823_7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSN7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f013
313195tamoxifen citrate 20 MG Oral TabletPSN7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f013
198240tamoxifen 10 MG Oral TabletSCD7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f013
313195tamoxifen 20 MG Oral TabletSCD7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f013
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f013
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSY7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0144-910037801449160 TABLET in 1 BOTTLE (0378-0144-91) 60 tablet2004-02-200000-00-00NoNoCurrent