FDA.reportPublic FDA data

Estradiol

Product NDC
0378-4643
11-digit product format
003784643
Labeler code
0378
Product ID
0378-4643_e1deb37a-8362-4275-a04c-7abcbb2e9f56
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA201675
Marketing category
ANDA
Marketing start
2014-12-19
Substance
ESTRADIOL
Active strength
.0375 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
Estradiol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.0375 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui241946, 242891, 242892, 248478, 1149632

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
0378-4643-16Estradiol3.5 d in 1 PATCHPATCH3.514
0378-4643-16Estradiol1 in 1 POUCHPATCH114
0378-4643-26Estradiol8 in 1 CARTONPATCH814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4643-16EA - Each0378-46432abb63c1-0d40-4dd3-bc7f-373a63e1802e12018-05-09
0378-4643-26EA - Each0378-4643e4fe80c3-f5cd-4dfe-af1a-a7ee72e8158412015-01-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C40ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4
POVIDONESINACTIVE INGREDIENTFZ989GH94EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4643ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 3 package rows20241220_d28bec8f-762e-4f05-a20d-96a42970d6a7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemPSNd28bec8f-762e-4f05-a20d-96a42970d6a714
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemPSNd28bec8f-762e-4f05-a20d-96a42970d6a714
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemPSNd28bec8f-762e-4f05-a20d-96a42970d6a714
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSNd28bec8f-762e-4f05-a20d-96a42970d6a714
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemPSNd28bec8f-762e-4f05-a20d-96a42970d6a714
24847884 HR estradiol 0.00104 MG/HR Transdermal SystemSCDd28bec8f-762e-4f05-a20d-96a42970d6a714
24194684 HR estradiol 0.00156 MG/HR Transdermal SystemSCDd28bec8f-762e-4f05-a20d-96a42970d6a714
24289184 HR estradiol 0.00208 MG/HR Transdermal SystemSCDd28bec8f-762e-4f05-a20d-96a42970d6a714
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCDd28bec8f-762e-4f05-a20d-96a42970d6a714
24289284 HR estradiol 0.00417 MG/HR Transdermal SystemSCDd28bec8f-762e-4f05-a20d-96a42970d6a714
248478estradiol 0.00104 MG/HR 84 HR Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
241946estradiol 0.00156 MG/HR 84 HR Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
242891estradiol 0.00208 MG/HR 84 HR Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
242892estradiol 0.00417 MG/HR 84 HR Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
248478estradiol 0.025 MG/Day Twice Weekly Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemSYd28bec8f-762e-4f05-a20d-96a42970d6a714
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemSYd28bec8f-762e-4f05-a20d-96a42970d6a714
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemSYd28bec8f-762e-4f05-a20d-96a42970d6a714
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSYd28bec8f-762e-4f05-a20d-96a42970d6a714
242892estradiol 0.1 MG/24HR Twice Weekly Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemSYd28bec8f-762e-4f05-a20d-96a42970d6a714
241946estradiol 37.5 MCG/Day Twice Weekly Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
242891estradiol 50 MCG/Day Twice Weekly Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSYd28bec8f-762e-4f05-a20d-96a42970d6a714

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-4643-16003784643163.5 d in 1 PATCH3.5 dHistorical
0378-4643-26003784643268 POUCH in 1 CARTON (0378-4643-26) / 1 PATCH in 1 POUCH (0378-4643-16) / 3.5 d in 1 PATCH8 pouch2014-12-190000-00-00NoNoCurrent