Estradiol

Product NDC
69238-1296
11-digit product format
692381296
Labeler code
69238
Product ID
69238-1296_257bffaf-8bc9-4557-a1e3-bab40bee2fb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211396
Marketing category
ANDA
Marketing start
2020-09-30
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

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
A211396-001ESTRADIOLESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28
A211396-002ESTRADIOLESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28
A211396-003ESTRADIOLESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28
A211396-004ESTRADIOLESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28
A211396-005ESTRADIOLESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A211396-001AB3
A211396-002AB3
A211396-003AB3
A211396-004AB3
A211396-005AB3

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 5 · 185 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-001ESTRADIOL0.025MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-002ESTRADIOL0.0375MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-003ESTRADIOL0.05MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-004ESTRADIOL0.075MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-005ESTRADIOL0.1MG/24HRFILM, EXTENDED RELEASE / TRANSDERMALAB32020-09-285bbf6a4d5a75…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 185 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A211396-001AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-002AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-003AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-004AB31011fe1cb6892…
2026-02-19 14:30 UTC2026-02A211396-005AB31011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-001AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-002AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-003AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-004AB3131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A211396-005AB3131067a03dcf5…
2025-08-23 18:47 UTC2025-08A211396-001AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-002AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-003AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-004AB316a471c1ec25d…
2025-08-23 18:47 UTC2025-08A211396-005AB316a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-001AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-002AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-003AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-004AB31fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A211396-005AB31fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-001AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-002AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-003AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-004AB31b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A211396-005AB31b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-001AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-002AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-003AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-004AB3103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A211396-005AB3103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-001AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-002AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-003AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-004AB312680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A211396-005AB312680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-001AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-002AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-003AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-004AB315bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A211396-005AB315bbf6a4d5a75…

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 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
d4259bb8-91f8-4587-8ceb-35d44145aec0Available 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
69238-1296-1Estradiol1 d in 1 POUCHPATCH, EXTENDED RELEASE111
69238-1296-7Estradiol8 in 1 CARTONPATCH, EXTENDED RELEASE811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1296ESTRADIOL PATCH, EXTENDED RELEASE [AMNEAL PHARMACEUTICALS NY LLC]11Current NDC, Legacy NDC, 2 package rows20240607_d4259bb8-91f8-4587-8ceb-35d44145aec0.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLAmneal Pharmaceuticals NY LLCd4259bb8-91f8-4587-8ceb-35d44145aec02024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211396
application number: ANDA211396
ndc (product): 69238-1296
LYLLANAESTRADIOLAmneal Pharmaceuticals LLC09c472c6-a38a-4a3d-b048-6fefd52e2ad32024-05-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 211396
application number: ANDA211396

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemPSNd4259bb8-91f8-4587-8ceb-35d44145aec011
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemPSNd4259bb8-91f8-4587-8ceb-35d44145aec011
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemPSNd4259bb8-91f8-4587-8ceb-35d44145aec011
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSNd4259bb8-91f8-4587-8ceb-35d44145aec011
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemPSNd4259bb8-91f8-4587-8ceb-35d44145aec011
24847884 HR estradiol 0.00104 MG/HR Transdermal SystemSCDd4259bb8-91f8-4587-8ceb-35d44145aec011
24194684 HR estradiol 0.00156 MG/HR Transdermal SystemSCDd4259bb8-91f8-4587-8ceb-35d44145aec011
24289184 HR estradiol 0.00208 MG/HR Transdermal SystemSCDd4259bb8-91f8-4587-8ceb-35d44145aec011
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCDd4259bb8-91f8-4587-8ceb-35d44145aec011
24289284 HR estradiol 0.00417 MG/HR Transdermal SystemSCDd4259bb8-91f8-4587-8ceb-35d44145aec011
248478estradiol 0.00104 MG/HR 84 HR Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
241946estradiol 0.00156 MG/HR 84 HR Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
242891estradiol 0.00208 MG/HR 84 HR Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
242892estradiol 0.00417 MG/HR 84 HR Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
248478estradiol 0.025 MG/Day Twice Weekly Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemSYd4259bb8-91f8-4587-8ceb-35d44145aec011
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemSYd4259bb8-91f8-4587-8ceb-35d44145aec011
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemSYd4259bb8-91f8-4587-8ceb-35d44145aec011
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSYd4259bb8-91f8-4587-8ceb-35d44145aec011
242892estradiol 0.1 MG/24HR Twice Weekly Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemSYd4259bb8-91f8-4587-8ceb-35d44145aec011
241946estradiol 37.5 MCG/Day Twice Weekly Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
242891estradiol 50 MCG/Day Twice Weekly Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSYd4259bb8-91f8-4587-8ceb-35d44145aec011

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69238-1296-1692381296011 d in 1 POUCH1 dHistorical
69238-1296-7692381296078 POUCH in 1 CARTON (69238-1296-7) / 1 d in 1 POUCH (69238-1296-1) 8 pouch2020-09-300000-00-00NoNoCurrent