ESTRADIOL

Product NDC
68788-7567
Requested package NDC
68788-7567-9
11-digit product format
687887567
Labeler code
68788
Product ID
68788-7567_e53d66bc-c827-4b8b-8f9f-b7236597cddc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA040275
Marketing category
ANDA
Marketing start
2017-04-10
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
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage68788-756768788-7567-9DDiscontinued by firm2026-08-07

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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

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
A040275-001ESTRADIOLESTRADIOL0.5MGTABLET / ORALAB1998-12-29
A040275-002ESTRADIOLESTRADIOL1MGTABLET / ORALAB1998-12-29
A040275-003ESTRADIOLESTRADIOL2MGTABLET / ORALAB1998-12-29

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A040275-001AB
A040275-002AB
A040275-003AB

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 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-29d06236e962d9…
2024-10-29 15:01 UTC2024-10A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040275-002ESTRADIOL1MGTABLET / ORALAB1998-12-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040275-003ESTRADIOL2MGTABLET / ORALAB1998-12-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040275-001ESTRADIOL0.5MGTABLET / ORALAB1998-12-298072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A040275-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040275-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040275-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040275-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040275-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040275-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040275-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040275-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040275-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040275-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040275-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040275-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040275-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040275-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040275-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040275-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040275-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040275-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040275-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040275-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040275-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040275-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040275-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040275-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040275-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040275-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040275-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040275-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040275-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040275-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040275-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040275-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040275-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040275-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040275-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040275-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040275-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040275-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040275-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040275-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

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 · 19 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ESTRADIOLESTRADIOLA-S Medication Solutions5c9a2e0f-704b-4d16-8ea3-d94f7f36ce6b2026-07-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLREMEDYREPACK INC.477cb52e-8ce2-491f-94a0-869ff60bf7ab2026-06-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLA-S Medication Solutionsafd70875-0a93-40a7-842e-f4359818c2d92026-05-27Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLREMEDYREPACK INC.170ec388-d399-4543-8743-208394b389042026-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLNorthwind Health Company, LLCf76aff99-f415-9045-e053-6294a90afd512026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLPreferred Pharmaceuticals Inc.9956a196-fefd-4766-a225-e154fbd3aeff2025-05-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLBryant Ranch Prepackfad3813c-9495-416b-9789-623d5758b4e32025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLBryant Ranch Prepackcf1ebc1d-8f3c-4468-b565-f0da69986e7c2025-03-28Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLBryant Ranch Prepackbfc1beb9-1ade-446e-97dd-55b41c2fa8512025-03-25Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLA-S Medication Solutions8788ddd1-36a6-416a-b527-75eb41de28082025-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLAsclemed USA, Inc.487ce40e-1f13-4497-994a-c5d91b87b6cc2025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
EstradiolESTRADIOLDirect_Rx032135ee-7bc9-5cdf-e063-6394a90ad9a22025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
EstradiolESTRADIOLDirect_Rx01789bad-4be4-ae22-e063-6294a90af3922025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLA-S Medication Solutions376beb31-5fed-4aae-a16f-71a7d243d5eb2025-01-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLPURACAP LABORATORIES, LLC97ace322-341a-4d52-8c63-17265ed9aa8d2025-01-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLEPIC PHARMA, LLC9333d92f-2585-4b99-aaea-87c01c95125e2025-01-07Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLNuCare Pharmaceuticals, Inc.5423c0da-eb10-20cd-e054-00144ff8d46c2024-07-17Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLNuCare Pharmaceuticals,Inc.7093dbe4-b096-2ddb-e053-2991aa0a1bb82024-06-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275
ESTRADIOLESTRADIOLAsclemed USA, Inc.229b4ec5-d3c8-4406-9fc5-8f633c6447b82022-10-12Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040275
application number: ANDA040275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-7567-96878875670990 TABLET in 1 BOTTLE (68788-7567-9) 90 tablet2019-12-270000-00-00NoNoCurrent