Estradiol

Product NDC
10544-070
11-digit product format
105440070
Labeler code
10544
Product ID
10544-070_1131085d-d458-1e3a-e054-00144ff8d46c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA040114
Marketing category
ANDA
Marketing start
2012-03-05
Marketing end
0000-00-00
Substance
ESTRADIOL
Active strength
2 mg/1
Pharmacologic classes
Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct10544-070IInactivated by FDA2026-09-14
excluded packagepackage10544-07010544-070-30IInactivated by FDA2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 44 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage10544-070-30IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage10544-070-30IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage10544-070-30IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage10544-070-30IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage10544-070-30IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage10544-070-30IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage10544-070-30IInactivated by FDA302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage10544-070-30IInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage10544-070-30IInactivated by FDA0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage10544-070-30IInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage10544-070-30IInactivated by FDA367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage10544-070-30IInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage10544-070-30IInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage10544-070-30IInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage10544-070-30IInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage10544-070-30IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage10544-070-30IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage10544-070-30IInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage10544-070-30IInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage10544-070-30IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage10544-070-30IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage10544-070-30EExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A040114-001ESTRADIOLESTRADIOL1MGTABLET / ORAL1996-03-14
A040114-002ESTRADIOLESTRADIOL2MGTABLET / ORAL1996-03-14
A040114-003ESTRADIOLESTRADIOL0.5MGTABLET / ORAL1996-03-14

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 · 129 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-1484e616aacf4f…
2026-09-14 22:38:342026-08A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-1484e616aacf4f…
2026-08-18 06:07:402026-07A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-14caaa826d4ba7…
2026-08-18 06:07:402026-07A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-14011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-1431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-146a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-14fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-14b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-1403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-142680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-145bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-14d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-14d06236e962d9…
2024-10-29 15:01 UTC2024-10A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040114-002ESTRADIOL2MGTABLET / ORAL1996-03-1479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040114-003ESTRADIOL0.5MGTABLET / ORAL1996-03-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040114-001ESTRADIOL1MGTABLET / ORAL1996-03-14301d65b070ca…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A040114-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040114-002AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A040114-003AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040114-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040114-002AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A040114-003AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040114-001AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040114-002AB1782e0a99824c…
2021-12-28 21:50 UTC2021-12A040114-003AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040114-001AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040114-002AB187673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040114-003AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040114-001AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040114-002AB15aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03A040114-003AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040114-001AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040114-002AB18869cabd3fbd…
2020-12-22 03:56 UTC2020-12A040114-003AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040114-001AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040114-002AB1c0c555d07b60…
2020-11-12 02:37 UTC2020-11A040114-003AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040114-001AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040114-002AB13f01610625f2…
2019-12-14 00:12 UTC2019-12A040114-003AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040114-001AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040114-002AB1b00525d2431f…
2019-09-15 20:21 UTC2019-09A040114-003AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040114-001AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040114-002AB1ea99ee380514…
2019-07-19 19:46 UTC2019-07A040114-003AB1ea99ee380514…

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10544-070-302020-01-31C16284748780-19d75b9cf-d751-f424-e053-dadaa90a57ceEstradiol Tablets USP

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
D&C RED NO. 30INACTIVE INGREDIENT2S42T2808BESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1
POLACRILIN POTASSIUMINACTIVE INGREDIENT0BZ5A00FQUESTRADIOL TABLET [BLENHEIM PHARMACAL, INC.]1