FDA.reportPublic FDA data

CombiPatch (estradiol/norethindrone acetate transdermal system)

Product NDC
68968-0525
11-digit product format
689680525
Labeler code
68968
Product ID
68968-0525_a8dddb67-4c56-4d1d-a4ce-83dc426d33f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol/norethindrone acetate transdermal system
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Noven Therapeutics, LLC
Application
NDA020870
Marketing category
NDA
Marketing start
1998-08-07
Substance
ESTRADIOL; NORETHINDRONE ACETATE
Active strength
.05; .25 mg/d; mg/d
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CombiPatch (estradiol/norethindrone acetate transdermal system)
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.05 mg/d
NORETHINDRONE ACETATE.25 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii9S44LIC7OJ, 4TI98Z838E
Rxcui1251493, 1251495, 1251499, 1251501

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
d39a542a-f5b0-4c2d-a820-0f5d39e6621fProduct name120250307
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
859c4b0b-8cba-4f41-9afe-cc181a01fb62Product name220240215
0d9f32e2-f85b-4d63-9f04-b06059c34749Product name320230323
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
cec4644c-0fed-4608-a5ea-d3a1b1b6d697Product name220200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424Product name620200716
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
c21bcd2e-ecbd-48e6-ab68-12cc12256c0fProduct name220190213
c6636356-4ccb-40e9-a952-59eb1f2fc859Product name420180806
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
e042bc86-5d40-8945-82f8-de9dd95420ddProduct name620180606
390e6d23-3a11-4327-9294-c958a378baaeProduct name420180124
b651f154-0364-4007-9dc6-9d33036db1d7Product name420170808
3395ac9b-f30b-4991-80ba-fd5196be0214Product name320170802
a5e2d962-d98c-4fbf-8183-ffd42dd01e19Product name620170711
00606b81-6e33-4c38-9ca9-bd14bd74d84cProduct name420170501
f4ce24e8-8632-4fad-9984-b693f985f80fProduct name320170501
b17c5419-b38b-579f-10bc-8a4ce69fc044Product name520170316
f6ac5560-6d3b-d281-41d2-adc50d283c20Product name320170228
01996782-abcb-4e6d-bcaf-4a23e6a95c0cProduct name120160714
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
2aecf0b6-88a0-49e5-92e1-983c700c116cProduct name120151222
61972742-5d4d-491d-a881-b6bc3a011577Product name120151113
23ede539-308f-46e5-817b-41ef23af8d40Product name120150930
425e3610-bbe8-4d70-9c46-8cf09afc4e4dProduct name120150930
5e13e814-349e-3480-99f3-ee22a591426fProduct name220150518
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3Product name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68968-0525-8CombiPatch (estradiol/norethindrone acetate transdermal system)1 in 1 POUCHPATCH, EXTENDED RELEASE114
68968-0525-8CombiPatch (estradiol/norethindrone acetate transdermal system)8 in 1 CARTONPATCH, EXTENDED RELEASE814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68968-0525-1EA - Each68968-0525426bc78e-9aff-4623-9ee7-ca5a00bc245212015-11-12
68968-0525-8EA - Each68968-0525904abe69-ba94-4836-ba9b-23c52a28048912014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838ECOMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]2
NORETHINDRONE ACETATEACTIVE INGREDIENT9S44LIC7OJCOMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]2
ESTRADIOLACTIVE MOIETY4TI98Z838ECOMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]2
NORETHINDRONEACTIVE MOIETYT18F433X4SCOMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]2
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPCOMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94ECOMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68968-0525COMBIPATCH (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) (ESTRADIOL/NORETHINDRONE ACETATE TRANSDERMAL SYSTEM) PATCH, EXTENDED RELEASE [NOVEN THERAPEUTICS, LLC]14Current NDC, Legacy NDC, 2 package rows20240224_83198ef1-11c4-11e4-9191-0800200c9a66.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1251495Combipatch 50/140 MCG/Day Twice Weekly Transdermal SystemPSN83198ef1-11c4-11e4-9191-0800200c9a6614
1251501Combipatch 50/250 MCG/Day Twice Weekly Transdermal SystemPSN83198ef1-11c4-11e4-9191-0800200c9a6614
1251493estradiol 50 MCG / norethindrone acetate 140 MCG/Day Twice Weekly Transdermal SystemPSN83198ef1-11c4-11e4-9191-0800200c9a6614
1251499estradiol 50 MCG / norethindrone acetate 250 MCG/Day Twice Weekly Transdermal SystemPSN83198ef1-11c4-11e4-9191-0800200c9a6614
125149584 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.00583 MG/HR Transdermal System [Combipatch]SBD83198ef1-11c4-11e4-9191-0800200c9a6614
125150184 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.0104 MG/HR Transdermal System [Combipatch]SBD83198ef1-11c4-11e4-9191-0800200c9a6614
125149384 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.00583 MG/HR Transdermal SystemSCD83198ef1-11c4-11e4-9191-0800200c9a6614
125149984 HR estradiol 0.00208 MG/HR / norethindrone acetate 0.0104 MG/HR Transdermal SystemSCD83198ef1-11c4-11e4-9191-0800200c9a6614
1251495CombiPatch 0.05/0.14 MG per 24HR Twice Weekly Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251501CombiPatch 0.05/0.25 MG per 24HR Twice Weekly Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251495Combipatch 50 MCG/140 MCG/Day Twice Weekly Transdermal SystemSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251501Combipatch 50/250 MCG/Day Twice Weekly Transdermal SystemSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251495Combipatch 84 HR (estradiol 0.00208 MG/HR / norethindrone acetate 0.00583 MG/HR) Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251501Combipatch 84 HR (estradiol 0.00208 MG/HR / norethindrone acetate 0.0104 MG/HR) Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251493estradiol 0.00208 MG / norethindrone acetate 0.00583 MG per HR 84 HR Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251499estradiol 0.00208 MG / norethindrone acetate 0.0104 MG per HR 84 HR Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251493estradiol 0.05 MG / norethindrone acetate 0.14 MG per Day Twice Weekly Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251499estradiol 0.05 MG / norethindrone acetate 0.25 MG per Day Twice Weekly Transdermal PatchSY83198ef1-11c4-11e4-9191-0800200c9a6614
1251493estradiol 50 MCG / norethindrone acetate 140 MCG/Day Twice Weekly Transdermal SystemSY83198ef1-11c4-11e4-9191-0800200c9a6614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68968-0525-8689680525088 POUCH in 1 CARTON (68968-0525-8) / 1 PATCH in 1 POUCH / 3.5 d in 1 PATCH8 pouch1998-08-070000-00-00NoNoCurrent