NDC 53746-226

Estradiol

Estradiol

Estradiol is a Vaginal Insert in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Of New York Llc. The primary component is Estradiol.

Product ID53746-226_1d902848-a592-4b0d-b550-36507c84e33f
NDC53746-226
Product TypeHuman Prescription Drug
Proprietary NameEstradiol
Generic NameEstradiol
Dosage FormInsert
Route of AdministrationVAGINAL
Marketing Start Date2015-06-07
Marketing CategoryANDA / ANDA
Application NumberANDA205256
Labeler NameAmneal Pharmaceuticals of New York LLC
Substance NameESTRADIOL
Active Ingredient Strength10 ug/1
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53746-226-21

8 APPLICATOR in 1 CARTON (53746-226-21) > 1 INSERT in 1 APPLICATOR
Marketing Start Date2015-06-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53746-226-21 [53746022621]

Estradiol INSERT
Marketing CategoryANDA
Application NumberANDA205256
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-07

NDC 53746-226-23 [53746022623]

Estradiol INSERT
Marketing CategoryANDA
Application NumberANDA205256
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-06-07

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL10 ug/1

OpenFDA Data

SPL SET ID:094830ee-1b1c-4cf7-8a39-427dfd56f9c9
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 884707
  • UPC Code
  • 0353746226211
  • 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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