Estradiol

Product NDC
70771-1567
11-digit product format
707711567
Labeler code
70771
Product ID
70771-1567_260eb67a-a1fc-4dae-9f69-345ea6ad9f83
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSDERMAL
Labeler
Zydus Lifesciences Limited
Application
ANDA206241
Marketing category
ANDA
Marketing start
2023-04-13
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 43.

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
A206241-001ESTRADIOLESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-01
A206241-002ESTRADIOLESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-01
A206241-003ESTRADIOLESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-01
A206241-004ESTRADIOLESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-01
A206241-005ESTRADIOLESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-01

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A206241-001AB1
A206241-002AB1
A206241-003AB1
A206241-004AB1
A206241-005AB1

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 4 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-0184e616aacf4f…
2026-09-14 22:38:342026-08A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-0184e616aacf4f…
2026-08-18 06:07:402026-07A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-01caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-01011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-0131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-016a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-01fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-01b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-001ESTRADIOL0.025MG/24HRSYSTEM / TRANSDERMALAB12022-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-002ESTRADIOL0.0375MG/24HRSYSTEM / TRANSDERMALAB12022-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-003ESTRADIOL0.05MG/24HRSYSTEM / TRANSDERMALAB12022-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-004ESTRADIOL0.075MG/24HRSYSTEM / TRANSDERMALAB12022-12-0103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-005ESTRADIOL0.1MG/24HRSYSTEM / TRANSDERMALAB12022-12-0103ed91905a0d…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 130 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A206241-001AB1184e616aacf4f…
2026-09-14 22:38:342026-08A206241-002AB1184e616aacf4f…
2026-09-14 22:38:342026-08A206241-003AB1184e616aacf4f…
2026-09-14 22:38:342026-08A206241-004AB1184e616aacf4f…
2026-09-14 22:38:342026-08A206241-005AB1184e616aacf4f…
2026-08-18 06:07:402026-07A206241-001AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-002AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-003AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-004AB11caaa826d4ba7…
2026-08-18 06:07:402026-07A206241-005AB11caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A206241-001AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-002AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-003AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-004AB11011fe1cb6892…
2026-02-19 14:30 UTC2026-02A206241-005AB11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-001AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-002AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-003AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-004AB1131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A206241-005AB1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A206241-001AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-002AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-003AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-004AB116a471c1ec25d…
2025-08-23 18:47 UTC2025-08A206241-005AB116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-001AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-002AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-003AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-004AB11fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A206241-005AB11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-001AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-002AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-003AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-004AB11b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A206241-005AB11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-001AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-002AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-003AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-004AB1103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A206241-005AB1103ed91905a0d…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
b79fd5ea-962f-491c-b670-40efe42ccf79Available 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
70771-1567-1Estradiol3.5 d in 1 PATCHPATCH, EXTENDED RELEASE3.51
70771-1567-1Estradiol1 in 1 POUCHPATCH, EXTENDED RELEASE11
70771-1567-8Estradiol8 in 1 BOXPATCH, EXTENDED RELEASE81

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1567ESTRADIOL PATCH, EXTENDED RELEASE [ZYDUS LIFESCIENCES LIMITED]1Current NDC, 3 package rows20230413_b79fd5ea-962f-491c-b670-40efe42ccf79.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
EstradiolESTRADIOLZydus Pharmaceuticals USA Inc.839fe7ae-6835-4d6a-b6b1-ca7f062caa4f2024-03-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 206241
application number: ANDA206241
EstradiolESTRADIOLZydus Lifesciences Limitedb79fd5ea-962f-491c-b670-40efe42ccf792022-12-07Exact identifier
application applno (ANDA): 206241
application number: ANDA206241
ndc (product): 70771-1567

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemPSNb79fd5ea-962f-491c-b670-40efe42ccf791
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemPSNb79fd5ea-962f-491c-b670-40efe42ccf791
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemPSNb79fd5ea-962f-491c-b670-40efe42ccf791
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemPSNb79fd5ea-962f-491c-b670-40efe42ccf791
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemPSNb79fd5ea-962f-491c-b670-40efe42ccf791
24847884 HR estradiol 0.00104 MG/HR Transdermal SystemSCDb79fd5ea-962f-491c-b670-40efe42ccf791
24194684 HR estradiol 0.00156 MG/HR Transdermal SystemSCDb79fd5ea-962f-491c-b670-40efe42ccf791
24289184 HR estradiol 0.00208 MG/HR Transdermal SystemSCDb79fd5ea-962f-491c-b670-40efe42ccf791
114963284 HR estradiol 0.00313 MG/HR Transdermal SystemSCDb79fd5ea-962f-491c-b670-40efe42ccf791
24289284 HR estradiol 0.00417 MG/HR Transdermal SystemSCDb79fd5ea-962f-491c-b670-40efe42ccf791
248478estradiol 0.00104 MG/HR 84 HR Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
241946estradiol 0.00156 MG/HR 84 HR Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
242891estradiol 0.00208 MG/HR 84 HR Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
1149632estradiol 0.00313 MG/HR 84 HR Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
242892estradiol 0.00417 MG/HR 84 HR Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
248478estradiol 0.025 MG/Day Twice Weekly Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
248478estradiol 0.025 MG/Day Twice Weekly Transdermal SystemSYb79fd5ea-962f-491c-b670-40efe42ccf791
241946estradiol 0.0375 MG/Day Twice Weekly Transdermal SystemSYb79fd5ea-962f-491c-b670-40efe42ccf791
242891estradiol 0.05 MG/Day Twice Weekly Transdermal SystemSYb79fd5ea-962f-491c-b670-40efe42ccf791
1149632estradiol 0.075 MG/Day Twice Weekly Transdermal SystemSYb79fd5ea-962f-491c-b670-40efe42ccf791
242892estradiol 0.1 MG/24HR Twice Weekly Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
242892estradiol 0.1 MG/Day Twice Weekly Transdermal SystemSYb79fd5ea-962f-491c-b670-40efe42ccf791
241946estradiol 37.5 MCG/Day Twice Weekly Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
242891estradiol 50 MCG/Day Twice Weekly Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791
1149632estradiol 75 MCG/Day Twice Weekly Transdermal PatchSYb79fd5ea-962f-491c-b670-40efe42ccf791

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70771-1567-1707711567013.5 d in 1 PATCH3.5 dHistorical
70771-1567-8707711567088 POUCH in 1 BOX (70771-1567-8) / 1 PATCH in 1 POUCH (70771-1567-1) / 3.5 d in 1 PATCH8 pouch2023-04-13NoNoCurrent