NDC 61919-194

ESTRADIOL

Estradiol

ESTRADIOL is a Oral Tablet in the Human Prescription Drug category. It is labeled and distributed by Directrx. The primary component is Estradiol.

Product ID61919-194_5daa7cf3-d88b-16a4-e053-2991aa0a4c08
NDC61919-194
Product TypeHuman Prescription Drug
Proprietary NameESTRADIOL
Generic NameEstradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-11-10
Marketing CategoryANDA / ANDA
Application NumberANDA040197
Labeler NameDirectRX
Substance NameESTRADIOL
Active Ingredient Strength1 mg/1
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC Exclude FlagE
Listing Certified Through2018-12-31

Packaging

NDC 61919-194-60

60 TABLET in 1 BOTTLE (61919-194-60)
Marketing Start Date2017-11-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 61919-194-60 [61919019460]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040197
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-10
Marketing End Date2019-09-18

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.5 mg/1

OpenFDA Data

SPL SET ID:b785a171-9d2d-425b-b812-0dddfbb4b71f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197657

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    68071-3326EstradiolEstradiol
    68071-3170EstradiolEstradiol
    68071-3202EstradiolEstradiol
    68071-3394ESTRADIOLESTRADIOL
    68071-4485ESTRADIOLESTRADIOL
    68071-4195EstradiolEstradiol
    68788-7054EstradiolEstradiol
    68788-7102ESTRADIOLESTRADIOL
    68788-7332ESTRADIOLESTRADIOL
    68788-9416EstradiolEstradiol
    68968-3410EstradiolEstradiol
    68968-3450EstradiolEstradiol
    68788-9901EstradiolEstradiol
    68968-3475EstradiolEstradiol
    68968-3425EstradiolEstradiol
    68968-3437EstradiolEstradiol
    69238-1630EstradiolEstradiol
    69238-1631EstradiolEstradiol
    69238-1629EstradiolEstradiol
    69238-1632EstradiolEstradiol
    69238-1633EstradiolEstradiol
    0555-0886EstradiolEstradiol
    0555-0887EstradiolEstradiol
    0555-0899EstradiolEstradiol
    70518-0920EstradiolEstradiol
    70518-0834EstradiolEstradiol
    71335-0226ESTRADIOLESTRADIOL
    71335-0430EstradiolEstradiol
    71335-0201EstradiolEstradiol
    71335-0797ESTRADIOLESTRADIOL
    71335-0445EstradiolEstradiol
    0781-7144EstradiolEstradiol
    0781-7129EstradiolEstradiol
    0781-7156EstradiolEstradiol
    0781-7138EstradiolEstradiol
    0781-7167EstradiolEstradiol
    10544-069EstradiolEstradiol
    10544-070EstradiolEstradiol
    0093-3541EstradiolEstradiol
    0093-3223EstradiolEstradiol
    21695-613EstradiolEstradiol
    21695-623EstradiolEstradiol
    23155-014EstradiolEstradiol
    23155-013EstradiolEstradiol
    23155-015EstradiolEstradiol
    33261-714EstradiolEstradiol
    33261-667EstradiolEstradiol
    42806-087ESTRADIOLESTRADIOL
    43063-706EstradiolEstradiol
    42806-089ESTRADIOLESTRADIOL
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