FDA.reportPublic FDA data

Tamoxifen Citrate

Product NDC
63739-269
11-digit product format
637390269
Labeler code
63739
Product ID
63739-269_b944fc3d-fdde-af43-e053-2a95a90a2ea8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA075797
Marketing category
ANDA
Marketing start
2003-02-20
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
2022-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63739-269-102023-01-30C16284748780-1ab0e2407-2ef1-f274-e053-dbdaa90a6471TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base) 0784 0782 Rx only
63739-269-422023-01-30C16284748780-1ab0e2407-2ef1-f274-e053-dbdaa90a6471TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base) 0784 0782 Rx only
63739-269-102020-07-22C16284748780-1ab0e2407-2ef1-f274-e053-dbdaa90a6471TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base) 0784 0782 Rx only
63739-269-422020-07-22C16284748780-1ab0e2407-2ef1-f274-e053-dbdaa90a6471TAMOXIFEN CITRATE TABLETS USP, 10 mg and 20 mg (base) 0784 0782 Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63739-269-10Tamoxifen Citrate10 in 1 BLISTER PACKTABLET, FILM COATED1011
63739-269-10Tamoxifen Citrate10 in 1 BOX, UNIT-DOSETABLET, FILM COATED1011
63739-269-42Tamoxifen Citrate60 in 1 BOTTLETABLET, FILM COATED6011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-269-10EA - Each63739-2690b50f78d-c8bc-470e-854e-ddafc4f9321d12012-07-24
63739-269-42EA - Each63739-2690d471273-61a4-43b9-9c14-c19e1997ec0d12019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMOXIFEN CITRATEACTIVE INGREDIENT7FRV7310N6TAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
TAMOXIFENACTIVE MOIETY094ZI81Y45TAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4TAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQTAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ETAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTAMOXIFEN CITRATE TABLET [MCKESSON PACKAGING SERVICES BUSINESS UNIT OF MCKESSON CORPORATION]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-269TAMOXIFEN CITRATE TABLET, FILM COATED [MCKESSON CORPORATION DBA SKY PACKAGING]11Legacy NDC, 3 package rows20210120_151ce76c-2d44-4c82-850d-ab213bea4d6b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSN151ce76c-2d44-4c82-850d-ab213bea4d6b11
198240tamoxifen 10 MG Oral TabletSCD151ce76c-2d44-4c82-850d-ab213bea4d6b11
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY151ce76c-2d44-4c82-850d-ab213bea4d6b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-269-106373902691010 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-269-10) > 10 TABLET, FILM COATED in 1 BLISTER PACK10 blister pack2003-02-200000-00-00NoNoCurrent
63739-269-426373902694260 in 1 BOTTLEHistorical