NDC 0781-7122

Estradiol Transdermal System

Estradiol

Estradiol Transdermal System is a Transdermal Patch in the Human Prescription Drug category. It is labeled and distributed by Sandoz Inc. The primary component is Estradiol.

Product ID0781-7122_42a9bee3-8d03-4f87-b55c-fbcb84a8ab8d
NDC0781-7122
Product TypeHuman Prescription Drug
Proprietary NameEstradiol Transdermal System
Generic NameEstradiol
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2003-05-27
Marketing CategoryNDA AUTHORIZED GENERIC / NDA AUTHORIZED GENERIC
Application NumberNDA020375
Labeler NameSandoz Inc
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 0781-7122-54

4 PATCH in 1 CARTON (0781-7122-54) > 7 d in 1 PATCH (0781-7122-58)
Marketing Start Date2018-08-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0781-7122-58 [00781712258]

Estradiol Transdermal System PATCH
Marketing CategoryNDA authorized generic
Application NumberNDA020375
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2003-05-27

NDC 0781-7122-54 [00781712254]

Estradiol Transdermal System PATCH
Marketing CategoryNDA authorized generic
Application NumberNDA020375
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-08-31

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.0375 mg/d

OpenFDA Data

SPL SET ID:c714974b-766f-42f2-a846-b0c1f5a60560
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 403922
  • 403923
  • 242333
  • 241527
  • 238003
  • 238004
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Estradiol Transdermal System" or generic name "Estradiol"

    NDCBrand NameGeneric Name
    0781-7122Estradiol Transdermal SystemEstradiol Transdermal System
    0781-7133Estradiol Transdermal SystemEstradiol Transdermal System
    0781-7134Estradiol Transdermal SystemEstradiol Transdermal System
    0781-7104Estradiol Transdermal SystemEstradiol Transdermal System
    0781-7119Estradiol Transdermal SystemEstradiol Transdermal System
    0781-7136Estradiol Transdermal SystemEstradiol Transdermal System
    47781-204Estradiol Transdermal SystemEstradiol Transdermal System
    47781-206Estradiol Transdermal SystemEstradiol Transdermal System
    47781-207Estradiol Transdermal SystemEstradiol Transdermal System
    47781-209Estradiol Transdermal SystemEstradiol Transdermal System
    47781-205Estradiol Transdermal SystemEstradiol Transdermal System
    47781-208Estradiol Transdermal SystemEstradiol Transdermal System
    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

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.