combipatch (estradiol/norethindrone acetate transdermal system)

Generic: estradiol/norethindrone acetate transdermal system

Labeler: noven therapeutics, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name combipatch (estradiol/norethindrone acetate transdermal system)
Generic Name estradiol/norethindrone acetate transdermal system
Labeler noven therapeutics, llc
Dosage Form PATCH, EXTENDED RELEASE
Routes
TRANSDERMAL
Active Ingredients

estradiol .05 mg/d, norethindrone acetate .14 mg/d

Manufacturer
Noven Therapeutics, LLC

Identifiers & Regulatory

Product NDC 68968-0514
Product ID 68968-0514_a8dddb67-4c56-4d1d-a4ce-83dc426d33f6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020870
Listing Expiration 2026-12-31
Marketing Start 1998-08-07

Pharmacologic Class

Established (EPC)
estrogen [epc]
Mechanism of Action
estrogen receptor agonists [moa]
Chemical Structure
estradiol congeners [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 689680514
Hyphenated Format 68968-0514

Supplemental Identifiers

RxCUI
1251493 1251495 1251499 1251501
UNII
9S44LIC7OJ 4TI98Z838E
NUI
M0447348 N0000175825 N0000000100

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name combipatch (estradiol/norethindrone acetate transdermal system) (source: ndc)
Generic Name estradiol/norethindrone acetate transdermal system (source: ndc)
Application Number NDA020870 (source: ndc)
Routes
TRANSDERMAL
source: ndc

Resolved Composition

Strengths
  • .05 mg/d
  • .14 mg/d
source: ndc
Packaging
  • 8 POUCH in 1 CARTON (68968-0514-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH
source: ndc

Packages (1)

68968-0514-8 8 POUCH in 1 CARTON (68968-0514-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH

Ingredients (2)

estradiol (.05 mg/d) norethindrone acetate (.14 mg/d)

Linked Drug Pages (1)

CombiPatch (estradiol/norethindrone acetate transdermal system) ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TRANSDERMAL"], "spl_id": "a8dddb67-4c56-4d1d-a4ce-83dc426d33f6", "openfda": {"nui": ["M0447348", "N0000175825", "N0000000100"], "unii": ["9S44LIC7OJ", "4TI98Z838E"], "rxcui": ["1251493", "1251495", "1251499", "1251501"], "spl_set_id": ["83198ef1-11c4-11e4-9191-0800200c9a66"], "pharm_class_cs": ["Estradiol Congeners [CS]"], "pharm_class_epc": ["Estrogen [EPC]"], "pharm_class_moa": ["Estrogen Receptor Agonists [MoA]"], "manufacturer_name": ["Noven Therapeutics, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "8 POUCH in 1 CARTON (68968-0514-8)  / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH", "package_ndc": "68968-0514-8", "marketing_start_date": "19980807"}], "brand_name": "CombiPatch (estradiol/norethindrone acetate transdermal system)", "product_id": "68968-0514_a8dddb67-4c56-4d1d-a4ce-83dc426d33f6", "dosage_form": "PATCH, EXTENDED RELEASE", "pharm_class": ["Estradiol Congeners [CS]", "Estrogen Receptor Agonists [MoA]", "Estrogen [EPC]", "Progesterone Congeners [CS]", "Progestin [EPC]"], "product_ndc": "68968-0514", "generic_name": "estradiol/norethindrone acetate transdermal system", "labeler_name": "Noven Therapeutics, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "CombiPatch (estradiol/norethindrone acetate transdermal system)", "active_ingredients": [{"name": "ESTRADIOL", "strength": ".05 mg/d"}, {"name": "NORETHINDRONE ACETATE", "strength": ".14 mg/d"}], "application_number": "NDA020870", "marketing_category": "NDA", "marketing_start_date": "19980807", "listing_expiration_date": "20261231"}