NDC 71335-0797

ESTRADIOL

Estradiol

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

Product ID71335-0797_495275ec-89ee-4865-9379-1de5db4a4a87
NDC71335-0797
Product TypeHuman Prescription Drug
Proprietary NameESTRADIOL
Generic NameEstradiol
Dosage FormTablet
Route of AdministrationORAL
Marketing Start Date2017-04-10
Marketing CategoryANDA / ANDA
Application NumberANDA040275
Labeler NameBryant Ranch Prepack
Substance NameESTRADIOL
Active Ingredient Strength1 mg/1
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 71335-0797-1

100 TABLET in 1 BOTTLE (71335-0797-1)
Marketing Start Date2018-05-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-0797-1 [71335079701]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-02

NDC 71335-0797-3 [71335079703]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-02

NDC 71335-0797-6 [71335079706]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-02

NDC 71335-0797-4 [71335079704]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-02

NDC 71335-0797-5 [71335079705]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-02

NDC 71335-0797-2 [71335079702]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040275
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2018-05-02

NDC 71335-0797-7 [71335079707]

ESTRADIOL TABLET
Marketing CategoryANDA
Application NumberANDA040275
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-05-02

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL1 mg/1

OpenFDA Data

SPL SET ID:fad3813c-9495-416b-9789-623d5758b4e3
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 197658
  • 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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