NDC 69238-1633

Estradiol

Estradiol

Estradiol is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Amneal Pharmaceuticals Ny Llc. The primary component is Estradiol.

Product ID69238-1633_5843fdea-342e-4524-a4f5-e74faf379909
NDC69238-1633
Product TypeHuman Prescription Drug
Proprietary NameEstradiol
Generic NameEstradiol
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date2019-02-04
Marketing CategoryANDA / ANDA
Application NumberANDA211293
Labeler NameAmneal Pharmaceuticals NY LLC
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 69238-1633-7

8 POUCH in 1 CARTON (69238-1633-7) > 1 d in 1 POUCH (69238-1633-1)
Marketing Start Date2019-02-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 69238-1633-1 [69238163301]

Estradiol PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-04

NDC 69238-1633-7 [69238163307]

Estradiol PATCH, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA211293
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-04

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.1 mg/d

OpenFDA Data

SPL SET ID:0500ee9b-bf4a-4432-9afe-20a7d60a6fe5
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 241946
  • 242891
  • 242892
  • 1149632
  • 248478
  • UPC Code
  • 0369238163315
  • 0369238163216
  • 0369238162912
  • 0369238163377
  • 0369238162974
  • 0369238163179
  • 0369238163278
  • 0369238163117
  • 0369238163018
  • 0369238163070
  • 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

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