NDC 68968-0514

CombiPatch (estradiol/norethindrone acetate transdermal system)

Estradiol/norethindrone Acetate Transdermal System

CombiPatch (estradiol/norethindrone acetate transdermal system) is a Transdermal Patch, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Noven Therapeutics, Llc. The primary component is Estradiol; Norethindrone Acetate.

Product ID68968-0514_571a6597-7561-441c-a89e-5e7acfa87ee2
NDC68968-0514
Product TypeHuman Prescription Drug
Proprietary NameCombiPatch (estradiol/norethindrone acetate transdermal system)
Generic NameEstradiol/norethindrone Acetate Transdermal System
Dosage FormPatch, Extended Release
Route of AdministrationTRANSDERMAL
Marketing Start Date1998-08-07
Marketing CategoryNDA / NDA
Application NumberNDA020870
Labeler NameNoven Therapeutics, LLC
Substance NameESTRADIOL; NORETHINDRONE ACETATE
Active Ingredient Strength0 mg/d; mg/d
Pharm ClassesEstradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 68968-0514-8

8 POUCH in 1 CARTON (68968-0514-8) > 1 PATCH in 1 POUCH (68968-0514-1) > 3.5 d in 1 PATCH
Marketing Start Date1998-08-07
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 68968-0514-1 [68968051401]

CombiPatch (estradiol/norethindrone acetate transdermal system) PATCH, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020870
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-08-07

NDC 68968-0514-8 [68968051408]

CombiPatch (estradiol/norethindrone acetate transdermal system) PATCH, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA020870
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1998-08-07

Drug Details

Active Ingredients

IngredientStrength
ESTRADIOL.05 mg/d

OpenFDA Data

SPL SET ID:83198ef1-11c4-11e4-9191-0800200c9a66
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1251495
  • 1251501
  • 1251499
  • 1251493
  • Pharmacological Class

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

    Medicade Reported Pricing

    68968051408 COMBIPATCH 0.05-0.14 MG PTCH

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "CombiPatch (estradiol/norethindrone acetate transdermal system)" or generic name "Estradiol/norethindrone Acetate Transdermal System"

    NDCBrand NameGeneric Name
    68968-0514CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal system
    68968-0525CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal system

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