FDA.reportPublic FDA data

DOTTI

Product NDC
65162-995
11-digit product format
651620995
Labeler code
65162
Product ID
65162-995_d26f45d5-79c5-429a-bb0f-44c58fa0b569
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Amneal Pharmaceuticals LLC
Application
ANDA211293
Marketing category
ANDA
Marketing start
2019-02-04
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
DOTTI
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, 1149632, 2110774, 2110777, 2110780, 2110783, 2110786

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
65162-995-04DOTTI1 d in 1 POUCHPATCH, EXTENDED RELEASE110
65162-995-08DOTTI8 in 1 CARTONPATCH, EXTENDED RELEASE810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65162-995-04EA - Each65162-995a54d9925-5a8a-4369-a682-db8697da4f6312019-07-02
65162-995-08EA - Each65162-995423137f5-cc80-4d1c-9fdf-3c13bc809bdd12019-07-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65162-995DOTTI (ESTRADIOL) PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 2 package rows20240607_53016d30-6b5f-49da-ac16-85ef415a5805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2110783DOTTI 0.075 MG/Day Twice Weekly Transdermal SystemPSNb119df4a-c514-4804-b1a8-b09c6058e80d102
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSNb119df4a-c514-4804-b1a8-b09c6058e80d102
211078384 HR estradiol 0.00313 MG/HR Transdermal System [Dotti]SBDb119df4a-c514-4804-b1a8-b09c6058e80d102
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCDb119df4a-c514-4804-b1a8-b09c6058e80d102
211078384 HR Dotti 0.00313 MG/HR Transdermal SystemSYb119df4a-c514-4804-b1a8-b09c6058e80d102
2110783Dotti 0.075 MG/24HR Twice Weekly Transdermal SystemSYb119df4a-c514-4804-b1a8-b09c6058e80d102
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSYb119df4a-c514-4804-b1a8-b09c6058e80d102
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSYb119df4a-c514-4804-b1a8-b09c6058e80d102
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSYb119df4a-c514-4804-b1a8-b09c6058e80d102
2110774DOTTI 0.025 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
2110777DOTTI 0.0375 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
2110780DOTTI 0.05 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
2110783DOTTI 0.075 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
2110786DOTTI 0.1 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemPSN53016d30-6b5f-49da-ac16-85ef415a580510
211077484 HR estradiol 0.00104 MG/HR Transdermal System [Dotti]SBD53016d30-6b5f-49da-ac16-85ef415a580510
211077784 HR estradiol 0.00156 MG/HR Transdermal System [Dotti]SBD53016d30-6b5f-49da-ac16-85ef415a580510
211078084 HR estradiol 0.00208 MG/HR Transdermal System [Dotti]SBD53016d30-6b5f-49da-ac16-85ef415a580510
211078384 HR estradiol 0.00313 MG/HR Transdermal System [Dotti]SBD53016d30-6b5f-49da-ac16-85ef415a580510
211078684 HR estradiol 0.00417 MG/HR Transdermal System [Dotti]SBD53016d30-6b5f-49da-ac16-85ef415a580510
24847884 HR estradiol 0.00104 MG/HR Transdermal SystemSCD53016d30-6b5f-49da-ac16-85ef415a580510
24194684 HR estradiol 0.00156 MG/HR Transdermal SystemSCD53016d30-6b5f-49da-ac16-85ef415a580510
24289184 HR estradiol 0.00208 MG/HR Transdermal SystemSCD53016d30-6b5f-49da-ac16-85ef415a580510
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCD53016d30-6b5f-49da-ac16-85ef415a580510
24289284 HR estradiol 0.00417 MG/HR Transdermal SystemSCD53016d30-6b5f-49da-ac16-85ef415a580510
211077484 HR Dotti 0.00104 MG/HR Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
211077784 HR Dotti 0.00156 MG/HR Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
211078084 HR Dotti 0.00208 MG/HR Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
211078384 HR Dotti 0.00313 MG/HR Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
211078684 HR Dotti 0.00417 MG/HR Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
2110774Dotti 0.025 MG/24HR Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
2110777Dotti 0.0375 MG/24HR Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
2110780Dotti 0.05 MG/24HR Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
2110783Dotti 0.075 MG/24HR Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
2110786Dotti 0.1 MG/24HR Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
248478estradiol 0.00104 MG/HR 84 HR Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
241946estradiol 0.00156 MG/HR 84 HR Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
242891estradiol 0.00208 MG/HR 84 HR Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
242892estradiol 0.00417 MG/HR 84 HR Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
248478estradiol 0.025 MG/Day Twice Weekly Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
242892estradiol 0.1 MG/24HR Twice Weekly Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemSY53016d30-6b5f-49da-ac16-85ef415a580510
241946estradiol 37.5 MCG/Day Twice Weekly Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
242891estradiol 50 MCG/Day Twice Weekly Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSY53016d30-6b5f-49da-ac16-85ef415a580510

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65162-995-04651620995041 d in 1 POUCH1 dHistorical
65162-995-08651620995088 POUCH in 1 CARTON (65162-995-08) / 1 d in 1 POUCH (65162-995-04) 8 pouch2019-02-040000-00-00NoNoCurrent