FDA.reportPublic FDA data

Tamoxifen Citrate

Product NDC
0591-2472
11-digit product format
005912472
Labeler code
0591
Product ID
0591-2472_20254a14-2e07-4279-8263-c63b6a71d861
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA070929
Marketing category
ANDA
Marketing start
2011-08-15
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
0591-2472-18Tamoxifen Citrate180 in 1 BOTTLE, PLASTICTABLET1808
0591-2472-60Tamoxifen Citrate60 in 1 BOTTLE, PLASTICTABLET608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-2472-18EA - Each0591-2472cd9fbb96-9e2c-4b8e-878a-52e2f511f1e012012-07-24
0591-2472-60EA - Each0591-2472575126dc-f20a-4f57-a358-91b9e07abc8b12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TAMOXIFEN CITRATEACTIVE INGREDIENT7FRV7310N6TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
TAMOXIFENACTIVE MOIETY094ZI81Y45TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XTAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJTAMOXIFEN CITRATE TABLET [WATSON LABORATORIES, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-2472TAMOXIFEN CITRATE TABLET [ACTAVIS PHARMA, INC.]6Current NDC, Legacy NDC, 2 package rows20220326_9b8a4211-120f-4981-ad69-928accb97637.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198240tamoxifen citrate 10 MG Oral TabletPSN8c0eb763-420a-4106-ba56-526b53a7f72b101
198240tamoxifen 10 MG Oral TabletSCD8c0eb763-420a-4106-ba56-526b53a7f72b101
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY8c0eb763-420a-4106-ba56-526b53a7f72b101
198240tamoxifen citrate 10 MG Oral TabletPSN8d731e7e-3b04-49a2-a0f6-3779422174cc13
198240tamoxifen 10 MG Oral TabletSCD8d731e7e-3b04-49a2-a0f6-3779422174cc13
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY8d731e7e-3b04-49a2-a0f6-3779422174cc13
198240tamoxifen citrate 10 MG Oral TabletPSN9b8a4211-120f-4981-ad69-928accb976378
313195tamoxifen citrate 20 MG Oral TabletPSN9b8a4211-120f-4981-ad69-928accb976378
198240tamoxifen 10 MG Oral TabletSCD9b8a4211-120f-4981-ad69-928accb976378
313195tamoxifen 20 MG Oral TabletSCD9b8a4211-120f-4981-ad69-928accb976378
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSY9b8a4211-120f-4981-ad69-928accb976378
313195tamoxifen 20 MG (as tamoxifen citrate 30.4 MG) Oral TabletSY9b8a4211-120f-4981-ad69-928accb976378
198240tamoxifen citrate 10 MG Oral TabletPSNa5615dbb-3c5e-6ccc-e053-2995a90ab6983
198240tamoxifen 10 MG Oral TabletSCDa5615dbb-3c5e-6ccc-e053-2995a90ab6983
198240tamoxifen 10 MG (as tamoxifen citrate 15.2 MG) Oral TabletSYa5615dbb-3c5e-6ccc-e053-2995a90ab6983

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-2472-1800591247218180 TABLET in 1 BOTTLE, PLASTIC (0591-2472-18) 180 tablet2011-08-150000-00-00NoNoCurrent
0591-2472-600059124726060 TABLET in 1 BOTTLE, PLASTIC (0591-2472-60) 60 tablet2011-08-150000-00-00NoNoCurrent