Tamoxifen Citrate

Product NDC
68071-5254
11-digit product format
680715254
Labeler code
68071
Product ID
68071-5254_1d78d7d4-4388-eab7-e063-6394a90a9e7f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Tamoxifen Citrate
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,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

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
68071-5254-32022-06-09C16284748780-1d6a99b39-d8db-a426-e053-dadaa90af4c2Tamoxifen Citrate Tabs_New NDC Codes 2472 2473
68071-5254-32022-01-28C16284748780-1d6a99b39-d8db-a426-e053-dadaa90af4c2Tamoxifen Citrate Tabs_New NDC Codes 2472 2473

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-5254-3Tamoxifen Citrate30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-5254TAMOXIFEN CITRATE TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, Legacy NDC, 1 package rows20240719_a5615dbb-3c5e-6ccc-e053-2995a90ab698.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
68071-5254-36807152540330 TABLET in 1 BOTTLE (68071-5254-3) 30 tablet2020-05-110000-00-00NoNoCurrent