Estradiol

Product NDC
0378-4644
11-digit product format
003784644
Labeler code
0378
Product ID
0378-4644_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
.025 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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 5 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A201675-001ESTRADIOLESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-19
A201675-002ESTRADIOLESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-19
A201675-003ESTRADIOLESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-19
A201675-004ESTRADIOLESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-19
A201675-005ESTRADIOLESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-19

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 5 matching rows.

Application-product, TE code table
Application-productTE code
A201675-001AB1
A201675-002AB1
A201675-003AB1
A201675-004AB1
A201675-005AB1

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12014-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12014-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12014-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12014-12-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12014-12-195bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A201675-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A201675-005AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-004AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201675-005AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A201675-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-004AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A201675-005AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-004AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201675-005AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-004AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201675-005AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-004AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201675-005AB1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-001AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-002AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-003AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-004AB112680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201675-005AB112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-001AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-002AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-003AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-004AB115bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201675-005AB115bbf6a4d5a75…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.025 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4TI98Z838EInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
241946Internal RxNorm lookup
242891Internal RxNorm lookup
242892Internal RxNorm lookup
248478Internal RxNorm lookup
1149632Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d28bec8f-762e-4f05-a20d-96a42970d6a7Available on FDA.report

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
0378-4644-16Estradiol3.5 d in 1 PATCHPATCH3.514
0378-4644-16Estradiol1 in 1 POUCHPATCH114
0378-4644-26Estradiol8 in 1 CARTONPATCH814

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-4644-16EA - Each0378-4644c7767638-10b3-4ddf-a8fd-9d161292f23312018-05-09
0378-4644-26EA - Each0378-4644670f7ffa-eeac-419d-9f45-54e37247e37612015-01-05

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
0378-4644ESTRADIOL PATCH [MYLAN PHARMACEUTICALS INC.]13Current NDC, Legacy NDC, 3 package rows20241220_d28bec8f-762e-4f05-a20d-96a42970d6a7.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLMylan Pharmaceuticals Inc.d28bec8f-762e-4f05-a20d-96a42970d6a72025-06-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 201675
application number: ANDA201675
ndc (product): 0378-4644

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
0378-4644-16003784644163.5 d in 1 PATCH3.5 dHistorical
0378-4644-26003784644268 POUCH in 1 CARTON (0378-4644-26) / 1 PATCH in 1 POUCH (0378-4644-16) / 3.5 d in 1 PATCH8 pouch2014-12-190000-00-00NoNoCurrent