FDA.reportPublic FDA data

Vivelle-Dot

Product NDC
66758-148
11-digit product format
667580148
Labeler code
66758
Product ID
66758-148_8e8ae172-5a0d-4888-a825-0c6cfa1afac9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Sandoz Inc
Application
NDA020538
Marketing category
NDA
Marketing start
1999-01-08
Substance
ESTRADIOL
Active strength
.075 mg/d
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vivelle-Dot
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.075 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui241946, 242891, 242892, 248478, 284378, 310172, 310176, 310183, 1149632, 1149634

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66758-148-40Vivelle-Dot8 in 1 BOXPATCH, EXTENDED RELEASE817
66758-148-40Vivelle-Dot3 in 1 CARTONPATCH, EXTENDED RELEASE317
66758-148-58Vivelle-Dot3.5 d in 1 PATCHPATCH, EXTENDED RELEASE3.517
66758-148-58Vivelle-Dot1 in 1 POUCHPATCH, EXTENDED RELEASE117
66758-148-83Vivelle-Dot8 in 1 BOXPATCH, EXTENDED RELEASE817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66758-148VIVELLE-DOT (ESTRADIOL) PATCH, EXTENDED RELEASE [SANDOZ INC]17Current NDC, 5 package rows20240704_5ccb77f9-d47b-4381-ad5c-5b92524e1c4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
284378Vivelle dot 0.025 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310172Vivelle dot 0.0375 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310176Vivelle dot 0.05 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
1149634Vivelle dot 0.075 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310183Vivelle dot 0.1 MG/Day Twice Weekly Transdermal SystemPSN5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
28437884 HR estradiol 0.00104 MG/HR Transdermal System [Vivelle]SBD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
31017284 HR estradiol 0.00156 MG/HR Transdermal System [Vivelle]SBD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
31017684 HR estradiol 0.00208 MG/HR Transdermal System [Vivelle]SBD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
114963484 HR estradiol 0.00313 MG/HR Transdermal System [Vivelle]SBD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
31018384 HR estradiol 0.00417 MG/HR Transdermal System [Vivelle]SBD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
24847884 HR estradiol 0.00104 MG/HR Transdermal SystemSCD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
24194684 HR estradiol 0.00156 MG/HR Transdermal SystemSCD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
24289184 HR estradiol 0.00208 MG/HR Transdermal SystemSCD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
24289284 HR estradiol 0.00417 MG/HR Transdermal SystemSCD5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
28437884 HR Vivelle 0.00104 MG/HR Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
31017284 HR Vivelle 0.00156 MG/HR Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
31017684 HR Vivelle 0.00208 MG/HR Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
114963484 HR Vivelle 0.00313 MG/HR Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
31018384 HR Vivelle 0.00417 MG/HR Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
248478estradiol 0.00104 MG/HR 84 HR Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
241946estradiol 0.00156 MG/HR 84 HR Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242891estradiol 0.00208 MG/HR 84 HR Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242892estradiol 0.00417 MG/HR 84 HR Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
248478estradiol 0.025 MG/Day Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242892estradiol 0.1 MG/24HR Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
241946estradiol 37.5 MCG/Day Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
242891estradiol 50 MCG/Day Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
284378Vivelle 0.025 MG/24HR Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310183Vivelle 0.1 MG/24HR Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
284378Vivelle dot 0.025 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310172Vivelle dot 0.0375 MG/24HR Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310172Vivelle dot 0.0375 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310176Vivelle Dot 0.05 MG/24HR Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310176Vivelle dot 0.05 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
1149634Vivelle Dot 0.075 MG/24HR Twice Weekly Transdermal PatchSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
1149634Vivelle dot 0.075 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17
310183Vivelle dot 0.1 MG/Day Twice Weekly Transdermal SystemSY5ccb77f9-d47b-4381-ad5c-5b92524e1c4a17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
66758-148-40667580148408 in 1 BOXHistorical
66758-148-58667580148583.5 d in 1 PATCH3.5 dHistorical
66758-148-83667580148838 POUCH in 1 BOX (66758-148-83) / 1 PATCH in 1 POUCH (66758-148-58) / 3.5 d in 1 PATCH8 pouch2024-07-01NoNoCurrent