ESTRADIOL

Product NDC
71335-0226
11-digit product format
713350226
Labeler code
71335
Product ID
71335-0226_4593e1f2-65b0-4a0f-ac69-0f2be718c63e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040275
Marketing category
ANDA
Marketing start
2017-04-10
Substance
ESTRADIOL
Active strength
.5 mg/1
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 · 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…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.5 mg/1

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197657Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
fad3813c-9495-416b-9789-623d5758b4e3Available 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
71335-0226-1ESTRADIOL30 in 1 BOTTLETABLET309
71335-0226-2ESTRADIOL100 in 1 BOTTLETABLET1009
71335-0226-3ESTRADIOL90 in 1 BOTTLETABLET909
71335-0226-4ESTRADIOL60 in 1 BOTTLETABLET609

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0226ESTRADIOL TABLET [BRYANT RANCH PREPACK]9Current NDC, Legacy NDC, 4 package rows20250331_fad3813c-9495-416b-9789-623d5758b4e3.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 · 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
ndc (product): 71335-0226
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197657estradiol 0.5 MG Oral TabletPSNfad3813c-9495-416b-9789-623d5758b4e39
197657estradiol 0.5 MG Oral TabletSCDfad3813c-9495-416b-9789-623d5758b4e39

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0226-17133502260130 TABLET in 1 BOTTLE (71335-0226-1) 30 tablet2018-06-290000-00-00NoNoCurrent
71335-0226-271335022602100 TABLET in 1 BOTTLE (71335-0226-2) 100 tablet2021-12-270000-00-00NoNoCurrent
71335-0226-37133502260390 TABLET in 1 BOTTLE (71335-0226-3) 90 tablet2018-05-070000-00-00NoNoCurrent
71335-0226-47133502260460 TABLET in 1 BOTTLE (71335-0226-4) 60 tablet2021-12-270000-00-00NoNoCurrent