NDC 0078-0365

Vivelle-Dot

Estradiol

Vivelle-Dot is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Novartis Pharmaceuticals Corporation. The primary component is Estradiol.

Product ID0078-0365_2740040f-a14a-4b53-83f7-842dd443081f
NDC0078-0365
Product TypeHuman Prescription Drug
Proprietary NameVivelle-Dot
Generic NameEstradiol
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date1999-01-08
Marketing CategoryNDA / NDA
Application NumberNDA020538
Labeler NameNovartis Pharmaceuticals Corporation
Substance NameESTRADIOL
Active Ingredient Strength0 mg/d
Pharm ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0078-0365-42

8 POUCH in 1 BOX (0078-0365-42) > 1 PATCH in 1 POUCH (0078-0365-62) > 3.5 d in 1 PATCH
Marketing Start Date2016-04-27
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0078-0365-45 [00078036545]

Vivelle-Dot PATCH, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020538
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1999-01-08

NDC 0078-0365-62 [00078036562]

Vivelle-Dot PATCH, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020538
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-02-28

NDC 0078-0365-42 [00078036542]

Vivelle-Dot PATCH, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020538
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-04-27

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.025 mg/d

OpenFDA Data

SPL SET ID:e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 310172
  • 242891
  • 248478
  • 242892
  • 241946
  • 1149632
  • 310176
  • 1149634
  • 284378
  • 310183
  • Pharmacological Class

    • Estradiol Congeners [CS]
    • Estrogen [EPC]
    • Estrogen Receptor Agonists [MoA]

    NDC Crossover Matching brand name "Vivelle-Dot" or generic name "Estradiol"

    NDCBrand NameGeneric Name
    0078-0343Vivelle-Dotestradiol
    0078-0344Vivelle-Dotestradiol
    0078-0345Vivelle-Dotestradiol
    0078-0346Vivelle-Dotestradiol
    0078-0365Vivelle-Dotestradiol
    0023-5885AloraEstradiol
    0023-5886AloraEstradiol
    0023-5887AloraEstradiol
    0023-5888AloraEstradiol
    0037-4801ELESTRINESTRADIOL
    0037-4802ELESTRINESTRADIOL
    0013-2150Estringestradiol

    Trademark Results [Vivelle-Dot]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    VIVELLE-DOT
    VIVELLE-DOT
    78822612 3180985 Live/Registered
    Novartis AG
    2006-02-24
    VIVELLE-DOT
    VIVELLE-DOT
    78159579 not registered Dead/Abandoned
    Noven Pharmaceuticals, Inc.
    2002-08-30

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