NDC 0378-0144

Tamoxifen Citrate

Tamoxifen Citrate

Tamoxifen Citrate is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Tamoxifen Citrate.

Product ID0378-0144_05bc57d8-48a4-40ef-ac05-5c2dd8ba1145
NDC0378-0144
Product TypeHuman Prescription Drug
Proprietary NameTamoxifen Citrate
Generic NameTamoxifen Citrate
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2003-02-20
Marketing CategoryANDA / ANDA
Application NumberANDA074732
Labeler NameMylan Pharmaceuticals Inc.
Substance NameTAMOXIFEN CITRATE
Active Ingredient Strength10 mg/1
Pharm ClassesEstrogen Agonist/Antagonist [EPC], Selective Estrogen Receptor Modulators [MoA]
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 0378-0144-91

60 TABLET in 1 BOTTLE (0378-0144-91)
Marketing Start Date2004-02-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0144-05 [00378014405]

Tamoxifen Citrate TABLET
Marketing CategoryANDA
Application NumberANDA074732
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-02-20
Marketing End Date2018-01-23

NDC 0378-0144-91 [00378014491]

Tamoxifen Citrate TABLET
Marketing CategoryANDA
Application NumberANDA074732
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2004-02-20

Drug Details

Active Ingredients

IngredientStrength
TAMOXIFEN CITRATE10 mg/1

OpenFDA Data

SPL SET ID:7ee3d3d2-85d1-4018-8e70-5ed8a64ae1f0
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 313195
  • 198240

    • Pharmacological Class

    • Estrogen Agonist/Antagonist [EPC]
    • Selective Estrogen Receptor Modulators [MoA]
    • Estrogen Agonist/Antagonist [EPC]
    • Selective Estrogen Receptor Modulators [MoA]

    NDC Crossover Matching brand name "Tamoxifen Citrate" or generic name "Tamoxifen Citrate"

    NDCBrand NameGeneric Name
    0179-0224Tamoxifen CitrateTamoxifen Citrate
    0378-0144Tamoxifen CitrateTamoxifen Citrate
    0378-0274Tamoxifen CitrateTamoxifen Citrate
    0591-2472Tamoxifen CitrateTamoxifen Citrate
    0591-2473Tamoxifen CitrateTamoxifen Citrate
    50090-0485Tamoxifen CitrateTamoxifen Citrate
    50090-0942Tamoxifen CitrateTamoxifen Citrate
    51407-439Tamoxifen CitrateTamoxifen Citrate
    51407-440Tamoxifen CitrateTamoxifen Citrate
    51862-446Tamoxifen CitrateTamoxifen Citrate
    51862-447Tamoxifen CitrateTamoxifen Citrate
    51862-449Tamoxifen CitrateTamoxifen Citrate
    51862-450Tamoxifen CitrateTamoxifen Citrate
    51862-642Tamoxifen CitrateTamoxifen Citrate
    51862-643Tamoxifen CitrateTamoxifen Citrate
    59651-299Tamoxifen CitrateTamoxifen Citrate
    59651-300Tamoxifen CitrateTamoxifen Citrate
    60429-909Tamoxifen CitrateTamoxifen Citrate
    60429-910Tamoxifen CitrateTamoxifen Citrate
    68382-827Tamoxifen CitrateTamoxifen Citrate
    68382-826Tamoxifen CitrateTamoxifen Citrate
    70518-1881Tamoxifen CitrateTamoxifen Citrate
    70771-1184Tamoxifen CitrateTamoxifen Citrate
    70771-1185Tamoxifen CitrateTamoxifen Citrate
    71335-0237Tamoxifen CitrateTamoxifen Citrate
    71335-0893Tamoxifen CitrateTamoxifen Citrate
    71335-0662Tamoxifen CitrateTamoxifen Citrate
    63187-976Tamoxifen CitrateTamoxifen Citrate
    63739-269Tamoxifen CitrateTamoxifen Citrate
    65084-269Tamoxifen CitrateTamoxifen Citrate
    68071-5005Tamoxifen CitrateTamoxifen Citrate
    71335-1424Tamoxifen CitrateTamoxifen Citrate
    68071-5254Tamoxifen CitrateTamoxifen Citrate
    70518-2721Tamoxifen CitrateTamoxifen Citrate
    51862-682SOLTAMOXTAMOXIFEN CITRATE
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