FDA.reportPublic FDA data

Estradiol

Product NDC
0378-3352
11-digit product format
003783352
Labeler code
0378
Product ID
0378-3352_49f22eba-c5a4-4264-b905-6a8ff7e0d884
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
estradiol
Dosage form
PATCH
Route
TRANSDERMAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA075182
Marketing category
ANDA
Marketing start
2000-03-01
Substance
ESTRADIOL
Active strength
.1 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.1 mg/d

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4TI98Z838E
Rxcui238003, 238004, 241527, 242333, 403922, 403923

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
0378-3352-16Estradiol1 in 1 POUCHPATCH116
0378-3352-16Estradiol7 d in 1 PATCHPATCH716
0378-3352-99Estradiol4 in 1 CARTONPATCH416

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3352-16EA - Each0378-3352e4c2a455-93d5-4940-9edd-355ad7688d0212015-05-05
0378-3352-99EA - Each0378-335231db452d-48d8-46b9-a817-f0995c99a94812012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]9
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]9
POVIDONESINACTIVE INGREDIENTFZ989GH94EESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]9
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]9
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3352ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]15Current NDC, Legacy NDC, 3 package rows20240823_e7e6da3b-8485-1382-61c9-e9b369018b98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
242333estradiol 0.025 MG/Day Weekly Transdermal SystemPSNe7e6da3b-8485-1382-61c9-e9b369018b9816
403922estradiol 0.0375 MG/Day Weekly Transdermal SystemPSNe7e6da3b-8485-1382-61c9-e9b369018b9816
238003estradiol 0.05 MG/Day Weekly Transdermal SystemPSNe7e6da3b-8485-1382-61c9-e9b369018b9816
403923estradiol 0.06 MG/Day Weekly Transdermal SystemPSNe7e6da3b-8485-1382-61c9-e9b369018b9816
241527estradiol 0.075 MG/Day Weekly Transdermal SystemPSNe7e6da3b-8485-1382-61c9-e9b369018b9816
238004estradiol 0.1 MG/Day Weekly Transdermal SystemPSNe7e6da3b-8485-1382-61c9-e9b369018b9816
242333168 HR estradiol 0.00104 MG/HR Transdermal SystemSCDe7e6da3b-8485-1382-61c9-e9b369018b9816
403922168 HR estradiol 0.00156 MG/HR Transdermal SystemSCDe7e6da3b-8485-1382-61c9-e9b369018b9816
238003168 HR estradiol 0.00208 MG/HR Transdermal SystemSCDe7e6da3b-8485-1382-61c9-e9b369018b9816
403923168 HR estradiol 0.0025 MG/HR Transdermal SystemSCDe7e6da3b-8485-1382-61c9-e9b369018b9816
241527168 HR estradiol 0.00312 MG/HR Transdermal SystemSCDe7e6da3b-8485-1382-61c9-e9b369018b9816
238004168 HR estradiol 0.00417 MG/HR Transdermal SystemSCDe7e6da3b-8485-1382-61c9-e9b369018b9816
242333estradiol 0.025 MG/24HR Weekly Transdermal PatchSYe7e6da3b-8485-1382-61c9-e9b369018b9816
242333estradiol 0.025 MG/Day Weekly Transdermal SystemSYe7e6da3b-8485-1382-61c9-e9b369018b9816
403922estradiol 0.0375 MG/24HR Weekly Transdermal PatchSYe7e6da3b-8485-1382-61c9-e9b369018b9816
403922estradiol 0.0375 MG/Day Weekly Transdermal SystemSYe7e6da3b-8485-1382-61c9-e9b369018b9816
238003estradiol 0.05 MG/24HR Weekly Transdermal PatchSYe7e6da3b-8485-1382-61c9-e9b369018b9816
238003estradiol 0.05 MG/Day Weekly Transdermal SystemSYe7e6da3b-8485-1382-61c9-e9b369018b9816
403923estradiol 0.06 MG/24HR Weekly Transdermal PatchSYe7e6da3b-8485-1382-61c9-e9b369018b9816
403923estradiol 0.06 MG/Day Weekly Transdermal SystemSYe7e6da3b-8485-1382-61c9-e9b369018b9816
241527estradiol 0.075 MG/Day Weekly Transdermal PatchSYe7e6da3b-8485-1382-61c9-e9b369018b9816
241527estradiol 0.075 MG/Day Weekly Transdermal SystemSYe7e6da3b-8485-1382-61c9-e9b369018b9816
238004estradiol 0.1 MG per 24 HR Weekly Transdermal PatchSYe7e6da3b-8485-1382-61c9-e9b369018b9816
238004estradiol 0.1 MG/Day Weekly Transdermal SystemSYe7e6da3b-8485-1382-61c9-e9b369018b9816

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3352-16003783352161 in 1 POUCHHistorical
0378-3352-99003783352994 POUCH in 1 CARTON (0378-3352-99) / 1 PATCH in 1 POUCH (0378-3352-16) / 7 d in 1 PATCH4 pouch2000-03-010000-00-00NoNoCurrent