NDC 50261-110

IMVEXXY

Estradiol

IMVEXXY is a Vaginal Insert in the Human Prescription Drug category. It is labeled and distributed by Therapeuticsmd, Inc.. The primary component is Estradiol.

Product ID50261-110_259015d9-8736-4028-b93d-82c82fcd71a5
NDC50261-110
Product TypeHuman Prescription Drug
Proprietary NameIMVEXXY
Generic NameEstradiol
Dosage FormInsert
Route of AdministrationVAGINAL
Marketing Start Date2018-07-03
Marketing CategoryNDA / NDA
Application NumberNDA208564
Labeler NameTherapeuticsMD, Inc.
Substance NameESTRADIOL
Active Ingredient Strength10 ug/1
Pharm ClassesEstradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 50261-110-02

1 BLISTER PACK in 1 CARTON (50261-110-02) > 2 INSERT in 1 BLISTER PACK
Marketing Start Date2018-07-09
NDC Exclude FlagN
Sample Package?Y

NDC SPL Data Element Entries

NDC 50261-110-02 [50261011002]

IMVEXXY INSERT
Marketing CategoryNDA
Application NumberNDA208564
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-09

NDC 50261-110-08 [50261011008]

IMVEXXY INSERT
Marketing CategoryNDA
Application NumberNDA208564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-09

NDC 50261-110-18 [50261011018]

IMVEXXY INSERT
Marketing CategoryNDA
Application NumberNDA208564
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-07-09

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL10 ug/1

OpenFDA Data

SPL SET ID:104be9f2-a8f6-430e-9e01-2ee7cc1861f1
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 2054318
  • 2054316
  • 2054317
  • 2054315
  • 884707
  • 2048918
  • 2054310
  • 2054312
  • 2054313
  • 2048917
  • 2048916
  • 2054309
  • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    50261-110IMVEXXYIMVEXXY
    50261-104IMVEXXYIMVEXXY
    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 [IMVEXXY]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    IMVEXXY
    IMVEXXY
    87327869 5602058 Live/Registered
    TherapeuticsMD, Inc.
    2017-02-07

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