FDA.reportPublic FDA data

Vivelle-Dot

Product NDC
0078-0346
11-digit product format
000780346
Labeler code
0078
Product ID
0078-0346_2740040f-a14a-4b53-83f7-842dd443081f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Novartis Pharmaceuticals Corporation
Application
NDA020538
Marketing category
NDA
Marketing start
1999-01-08
Marketing end
0000-00-00
Substance
ESTRADIOL
Active strength
0 mg/d
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct 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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0346-42EA - Each0078-03463c61ca95-efd1-49b6-a118-fb9dc26ea4b612012-07-24
0078-0346-45EA - Each0078-034674660cd7-4c92-49b1-9fcc-745526a1f11b12012-07-24
0078-0346-62EA - Each0078-03467c1b2112-d06d-4801-9401-faefaf969f8112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EVIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]5
ESTRADIOLACTIVE MOIETY4TI98Z838EVIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]5
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]5
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVVIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]5
POVIDONESINACTIVE INGREDIENTFZ989GH94EVIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]5
ESTRADIOLACTIVE INGREDIENT4TI98Z838EVIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
ESTRADIOLACTIVE MOIETY4TI98Z838EVIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40VIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVVIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EVIVELLE DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0078-0346VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [NOVARTIS PHARMACEUTICALS CORPORATION]14Legacy NDC20220712_e6f2e7ed-41a9-4a53-ac80-0cb1fa2edcbf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
284378Vivelle dot 0.025 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
310172Vivelle dot 0.0375 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
310176Vivelle dot 0.05 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
1149634Vivelle dot 0.075 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
310183Vivelle dot 0.1 MG/Day Twice Weekly Transdermal SystemPSN03ab0226-b494-4607-8e8b-7381082fa7801
28437884 HR estradiol 0.00104 MG/HR Transdermal System [Vivelle]SBD03ab0226-b494-4607-8e8b-7381082fa7801
31017284 HR estradiol 0.00156 MG/HR Transdermal System [Vivelle]SBD03ab0226-b494-4607-8e8b-7381082fa7801
31017684 HR estradiol 0.00208 MG/HR Transdermal System [Vivelle]SBD03ab0226-b494-4607-8e8b-7381082fa7801
114963484 HR estradiol 0.00313 MG/HR Transdermal System [Vivelle]SBD03ab0226-b494-4607-8e8b-7381082fa7801
31018384 HR estradiol 0.00417 MG/HR Transdermal System [Vivelle]SBD03ab0226-b494-4607-8e8b-7381082fa7801
24847884 HR estradiol 0.00104 MG/HR Transdermal SystemSCD03ab0226-b494-4607-8e8b-7381082fa7801
24194684 HR estradiol 0.00156 MG/HR Transdermal SystemSCD03ab0226-b494-4607-8e8b-7381082fa7801
24289184 HR estradiol 0.00208 MG/HR Transdermal SystemSCD03ab0226-b494-4607-8e8b-7381082fa7801
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCD03ab0226-b494-4607-8e8b-7381082fa7801
24289284 HR estradiol 0.00417 MG/HR Transdermal SystemSCD03ab0226-b494-4607-8e8b-7381082fa7801
28437884 HR Vivelle 0.00104 MG/HR Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
31017284 HR Vivelle 0.00156 MG/HR Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
31017684 HR Vivelle 0.00208 MG/HR Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
114963484 HR Vivelle 0.00313 MG/HR Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
31018384 HR Vivelle 0.00417 MG/HR Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
248478estradiol 0.00104 MG/HR 84 HR Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
241946estradiol 0.00156 MG/HR 84 HR Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
242891estradiol 0.00208 MG/HR 84 HR Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
242892estradiol 0.00417 MG/HR 84 HR Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
248478estradiol 0.025 MG/Day Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
242892estradiol 0.1 MG/24HR Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
241946estradiol 37.5 MCG/Day Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
242891estradiol 50 MCG/Day Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
284378Vivelle 0.025 MG/24HR Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
310183Vivelle 0.1 MG/24HR Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
284378Vivelle dot 0.025 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
310172Vivelle dot 0.0375 MG/24HR Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
310172Vivelle dot 0.0375 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
310176Vivelle Dot 0.05 MG/24HR Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
310176Vivelle dot 0.05 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
1149634Vivelle Dot 0.075 MG/24HR Twice Weekly Transdermal PatchSY03ab0226-b494-4607-8e8b-7381082fa7801
1149634Vivelle dot 0.075 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801
310183Vivelle dot 0.1 MG/Day Twice Weekly Transdermal SystemSY03ab0226-b494-4607-8e8b-7381082fa7801

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0346-42000780346428 POUCH in 1 BOX (0078-0346-42) > 1 PATCH in 1 POUCH (0078-0346-62) > 3.5 d in 1 PATCH8 pouch2016-03-310000-00-00NoNoCurrent
0078-0346-45000780346453 BOX in 1 CARTON (0078-0346-45) > 8 POUCH in 1 BOX > 1 PATCH in 1 POUCH > 3.5 d in 1 PATCH3 box1999-01-080000-00-00NoNoCurrent