NDC Code(s) : 68968-0514-8, 68968-0525-8
Packager : Noven Therapeutics, LLC

Category : HUMAN PRESCRIPTION DRUG LABEL

DEA Schedule : none

Marketing Status : New Drug Application

INGREDIENTS AND APPEARANCE

CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal system PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68968-0514
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.05 mg in 1 d
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ)
(NORETHINDRONE - UNII:T18F433X4S) 		NORETHINDRONE ACETATE0.14 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL(UNII: E107L85C40)
OLEIC ACID(UNII: 2UMI9U37CP)
POVIDONE K30(UNII: U725QWY32X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68968-0514-88 in 1 CARTON 08/07/1998
11 in 1 POUCH
13.5 d in 1 PATCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020870 08/07/1998
CombiPatch (estradiol/norethindrone acetate transdermal system)estradiol/norethindrone acetate transdermal system PATCH, EXTENDED RELEASE
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68968-0525
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ESTRADIOL(UNII: 4TI98Z838E)
(ESTRADIOL - UNII:4TI98Z838E) 		ESTRADIOL0.05 mg in 1 d
NORETHINDRONE ACETATE(UNII: 9S44LIC7OJ)
(NORETHINDRONE - UNII:T18F433X4S) 		NORETHINDRONE ACETATE0.25 mg in 1 d
Inactive Ingredients
Ingredient Name Strength
DIPROPYLENE GLYCOL(UNII: E107L85C40)
OLEIC ACID(UNII: 2UMI9U37CP)
POVIDONE K30(UNII: U725QWY32X)
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1NDC:68968-0525-88 in 1 CARTON 08/07/1998
11 in 1 POUCH
13.5 d in 1 PATCH Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA020870 08/07/1998

LABELER - Noven Therapeutics, LLC(166888268)

REGISTRANT - Noven Pharmaceuticals, Inc.(148585441)

Establishment
Name Address ID/FEI Business Operations
Noven Pharmaceuticals, Inc. 148585441 analysis(68968-0514, 68968-0525), manufacture(68968-0514, 68968-0525)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - NDC - 68968-0514-8 CombiPatch Count - 50/140

NDC 68968-0514-8
Includes 8 Systems

See New Storage Requirements

Combipatch ® 50/140

(estradiol/norethindrone acetate transdermal system)

0.05/0.14 mg per day

Noven

www.combipatch.com

Twice-Weekly Rx Only

Combipatch® 50/140

(estradiol/norethindrone acetate transdermal system)

0.05/0.14 mg per day

Twice-Weekly Rx Only

Contains 0.62 mg estradiol USP and 2.7 mg norethindrone acetate (NETA) USP to provide 0.05/0.14 mg of estradiol/NETA per day.

Inactive components: a silicone and acrylic-based multi-polymeric adhesive, povidone USP, oleic acid NF, polyolefin laminate backing, polyester release liner and dipropylene glycol.

Dosage and Administration: For transdermal use only. See package insert. Allow patch to reach room temperature before application. DO NOT STORE UNPOUCHED.

Keep out of the reach of children.

Store Combipatch® refrigerated at 36°F to 46°F (2°C to 8°C)

See side panel for lot number and expiration date. www.combipatch.com

N3 68968-0514-8 0 302391-4

Noven

PLEASE READ THIS BEFORE APPLYING PATCH.

Allow patch to reach room temperature before application.

See reverse side for patient instructions.

pull To open here

LOT/EXP GTIN 00368968051480

969864

Mfd. By: Noven Pharmaceuticals, Inc.

Miami, Florida 33186

Dist. By Noven Therapeutics, LLC

Miami, Florida 33186

Combi patch Count - 50/140

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - NDC - 68968-0525-8 CombiPatch Count - 50/250

NDC 68968-0525-8

Includes 8 Systems

See New Storage Requirements

Combipatch® 50/250

(estradiol/norethindrone acetate transdermal system)

0.05/0.25 mg per day

Noven

www.combipatch.com

Twice-Weekly Rx Only

Combipatch® 50/250

(estradiol/norethindrone acetate transdermal system)

0.05/0.25 mg per day

Twice-Weekly Rx Only

Contains 0.51 mg estradiol USP and 4.8 mg norethindrone acetate (NETA) USP to provide 0.05/0.25 mg of estradiol/NETA per day.

Inactive components: a silicone and acrylic-based multi-polymeric adhesive, povidone USP, oleic acid NF, polyolefin laminate backing, polyester release liner and dipropylene glycol.

Dosage and Administration: For transdermal use only. See package insert. Allow patch to reach room temperature before application. DO NOT STORE UNPOUCHED.

Keep out of the reach of children.

Store Combipatch® refrigerated at 36°F to 46°F (2°C to 8°C)

See side panel for lot number and expiration date. www.combipatch.com

N3 68968-0525-8 0 302390-4

Noven

PLEASE READ THIS BEFORE APPLYING PATCH.

Allow patch to reach room temperature before application.

See reverse side for patient instructions.

pull To open here

LOT/EXP GTIN 00368968052586

969864

Mfd. By: Noven Pharmaceuticals, Inc.

Miami, Florida 33186

Dist. By Noven Therapeutics, LLC

Miami, Florida 33186

Combi patch Count - 50/250