NDC 65162-993

DOTTI

Estradiol

DOTTI is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Llc. The primary component is Estradiol.

Product ID65162-993_06c114ee-4dc1-4dd3-b96f-479ac31310f5
NDC65162-993
Product TypeHuman Prescription Drug
Proprietary NameDOTTI
Generic NameEstradiol
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2019-02-04
Marketing CategoryANDA / ANDA
Application NumberANDA211293
Labeler NameAmneal Pharmaceuticals LLC
Substance NameESTRADIOL
Active Ingredient Strength0 mg/d
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 65162-993-08

8 POUCH in 1 CARTON (65162-993-08) > 1 d in 1 POUCH (65162-993-04)
Marketing Start Date2019-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 65162-993-04 [65162099304]

DOTTI PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-04

NDC 65162-993-08 [65162099308]

DOTTI PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211293
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-02-04

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.05 mg/d

OpenFDA Data

SPL SET ID:53016d30-6b5f-49da-ac16-85ef415a5805
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2110786
  • 2110780
  • 2110783
  • 242891
  • 2110774
  • 2110777
  • 242892
  • 241946
  • 1149632
  • 248478
  • UPC Code
  • 0365162993080
  • 0365162995084
  • 0365162992083
  • 0365162997040
  • 0365162989083
  • 0365162997088
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    65162-997DOTTIDOTTI
    65162-989DOTTIDOTTI
    65162-995DOTTIDOTTI
    65162-993DOTTIDOTTI
    65162-992DOTTIDOTTI
    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 [DOTTI]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    DOTTI
    DOTTI
    98192985 not registered Live/Pending
    The Imagine Group, LLC
    2023-09-22
    DOTTI
    DOTTI
    97565516 not registered Live/Pending
    Dotti Inc.
    2022-08-25
    DOTTI
    DOTTI
    90120704 not registered Live/Pending
    Wu Meizhen
    2020-08-18
    DOTTI
    DOTTI
    88167435 not registered Live/Pending
    Amneal Pharmaceuticals LLC
    2018-10-24
    DOTTI
    DOTTI
    86917096 5138878 Live/Registered
    JSJ Furniture Corporation
    2016-02-23
    DOTTI
    DOTTI
    79338973 not registered Live/Pending
    THEREZIA PRODCOM SRL
    2022-03-17
    DOTTI
    DOTTI
    75864925 not registered Dead/Abandoned
    DBW S.r.L.
    1999-12-06
    DOTTI
    DOTTI
    74244531 1774276 Live/Registered
    NOVO FASHION LIMITED
    1992-02-10
    DOTTI
    DOTTI
    73233311 1155870 Dead/Cancelled
    Hale County State Bank, Plainview, Texas
    1979-10-01

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