NDC 0378-4643

Estradiol

Estradiol

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

Product ID0378-4643_48ea604c-d747-4264-930f-ecc35355dd60
NDC0378-4643
Product TypeHuman Prescription Drug
Proprietary NameEstradiol
Generic NameEstradiol
Dosage FormPatch
Route of AdministrationTRANSDERMAL
Marketing Start Date2014-12-19
Marketing CategoryANDA / ANDA
Application NumberANDA201675
Labeler NameMylan Pharmaceuticals Inc.
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 0378-4643-26

8 POUCH in 1 CARTON (0378-4643-26) > 1 PATCH in 1 POUCH (0378-4643-16) > 3.5 d in 1 PATCH
Marketing Start Date2014-12-19
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4643-16 [00378464316]

Estradiol PATCH
Marketing CategoryANDA
Application NumberANDA201675
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-19

NDC 0378-4643-26 [00378464326]

Estradiol PATCH
Marketing CategoryANDA
Application NumberANDA201675
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2014-12-19

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.0375 mg/d

OpenFDA Data

SPL SET ID:d28bec8f-762e-4f05-a20d-96a42970d6a7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 241946
  • 242891
  • 242892
  • 1149632
  • 248478
  • 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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