FDA.reportPublic FDA data

Estradiol

Product NDC
0378-4622
11-digit product format
003784622
Labeler code
0378
Product ID
0378-4622_e3b94477-b715-40f6-bbbb-fe52a87148dd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA206685
Marketing category
ANDA
Marketing start
2018-11-01
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
Estradiol
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

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
0378-4622-16Estradiol1 in 1 POUCHPATCH17
0378-4622-16Estradiol3.5 d in 1 PATCHPATCH3.57
0378-4622-26Estradiol8 in 1 CARTONPATCH87

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4622-16EA - Each0378-462231222b08-f6b9-4926-9c85-aa0ad8118b7412018-12-13
0378-4622-26EA - Each0378-46220c5cf425-0fa5-41a4-ae85-fc11e3c8ca8412018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-4622ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 package rows20250122_f4efb0bf-b96f-4e20-a0f2-0806ab92b2d4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemPSNf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemPSNf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemPSNf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSNf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemPSNf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
24847884 HR estradiol 0.00104 MG/HR Transdermal SystemSCDf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
24194684 HR estradiol 0.00156 MG/HR Transdermal SystemSCDf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
24289184 HR estradiol 0.00208 MG/HR Transdermal SystemSCDf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCDf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
24289284 HR estradiol 0.00417 MG/HR Transdermal SystemSCDf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
248478estradiol 0.00104 MG/HR 84 HR Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
241946estradiol 0.00156 MG/HR 84 HR Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242891estradiol 0.00208 MG/HR 84 HR Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242892estradiol 0.00417 MG/HR 84 HR Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
248478estradiol 0.025 MG/Day Twice Weekly Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242892estradiol 0.1 MG/24HR Twice Weekly Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
241946estradiol 37.5 MCG/Day Twice Weekly Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
242891estradiol 50 MCG/Day Twice Weekly Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSYf4efb0bf-b96f-4e20-a0f2-0806ab92b2d47

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-4622-16003784622161 in 1 POUCHHistorical
0378-4622-26003784622268 POUCH in 1 CARTON (0378-4622-26) / 1 PATCH in 1 POUCH (0378-4622-16) / 3.5 d in 1 PATCH8 pouch2018-11-010000-00-00NoNoCurrent