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 ID: 68968-0514_571a6597-7561-441c-a89e-5e7acfa87ee2
• NDC: 68968-0514
• Product Type: Human Prescription Drug
• Proprietary Name: CombiPatch (estradiol/norethindrone acetate transdermal system)
• Generic Name: Estradiol/norethindrone Acetate Transdermal System
• Dosage Form: Patch, Extended Release
• Route of Administration: TRANSDERMAL
• Marketing Start Date: 1998-08-07
• Marketing Category: NDA / NDA
• Application Number: NDA020870
• Labeler Name: Noven Therapeutics, LLC
• Substance Name: ESTRADIOL; NORETHINDRONE ACETATE
• Active Ingredient Strength: 0 mg/d; mg/d
• Pharm Classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2022-12-31

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 Date: 1998-08-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 68968-0514-1 [68968051401]

CombiPatch (estradiol/norethindrone acetate transdermal system) PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020870
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-08-07

NDC 68968-0514-8 [68968051408]

CombiPatch (estradiol/norethindrone acetate transdermal system) PATCH, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA020870
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1998-08-07

Drug Details

Active Ingredients

Ingredient	Strength
ESTRADIOL	.05 mg/d

OpenFDA Data

• SPL SET ID: 83198ef1-11c4-11e4-9191-0800200c9a66
• Manufacturer:
  • Noven Therapeutics, LLC
• UNII:
  • 9S44LIC7OJ
  • 4TI98Z838E
• 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"

NDC	Brand Name	Generic Name
68968-0514	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system
68968-0525	CombiPatch (estradiol/norethindrone acetate transdermal system)	estradiol/norethindrone acetate transdermal system