NDC 68968-6637

Minivelle

Estradiol

Minivelle is a Transdermal Film, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Noven Therapeutics, Llc. The primary component is Estradiol.

Product ID68968-6637_30ab0454-1dcf-4df5-a7f8-309011db4e62
NDC68968-6637
Product TypeHuman Prescription Drug
Proprietary NameMinivelle
Generic NameEstradiol
Dosage FormFilm, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2012-12-20
Marketing CategoryNDA / NDA
Application NumberNDA203752
Labeler NameNoven Therapeutics, LLC
Substance NameESTRADIOL
Active Ingredient Strength0 mg/d
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 68968-6637-8

8 POUCH in 1 PACKET (68968-6637-8) > 1 d in 1 POUCH (68968-6637-1)
Marketing Start Date2012-12-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68968-6637-8 [68968663708]

Minivelle FILM, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA203752
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-20

NDC 68968-6637-3 [68968663703]

Minivelle FILM, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA203752
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-12-20
Marketing End Date2014-10-07

NDC 68968-6637-1 [68968663701]

Minivelle FILM, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA203752
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-12-20

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.0375 mg/d

OpenFDA Data

SPL SET ID:6c5c47ab-28ee-11e1-bfc2-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1551622
  • 1357009
  • 242891
  • 248478
  • 242892
  • 1356979
  • 1356997
  • 241946
  • 1357007
  • 1149632
  • UPC Code
  • 0368968661016
  • 0368968667513
  • 0368968665014
  • 0368968663713
  • Pharmacological Class

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

    Medicade Reported Pricing

    68968663708 MINIVELLE 0.0375 MG PATCH

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Minivelle" or generic name "Estradiol"

    NDCBrand NameGeneric Name
    68968-6650MinivelleMinivelle
    68968-6675MinivelleMinivelle
    68968-6637MinivelleMinivelle
    68968-6610MinivelleMinivelle
    68968-6625MinivelleMinivelle
    0023-5885AloraEstradiol
    0023-5886AloraEstradiol
    0023-5887AloraEstradiol
    0023-5888AloraEstradiol
    0037-4801ELESTRINESTRADIOL
    0037-4802ELESTRINESTRADIOL
    0013-2150Estringestradiol
    0078-0343Vivelle-Dotestradiol
    0078-0344Vivelle-Dotestradiol
    0078-0345Vivelle-Dotestradiol
    0078-0346Vivelle-Dotestradiol
    0078-0365Vivelle-Dotestradiol

    Trademark Results [Minivelle]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    MINIVELLE
    MINIVELLE
    85843747 4417626 Live/Registered
    Noven Pharmaceuticals, Inc.
    2013-02-07
    MINIVELLE
    MINIVELLE
    85358505 4302108 Live/Registered
    Noven Pharmaceuticals, Inc.
    2011-06-28

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