Estradiol

Product NDC
71335-0445
11-digit product format
713350445
Labeler code
71335
Product ID
71335-0445_5f5f09d7-aaf1-4926-9ed5-7bc5f3fa20b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA040197
Marketing category
ANDA
Marketing start
1997-10-28
Substance
ESTRADIOL
Active strength
1 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
A040197-001ESTRADIOLESTRADIOL0.5MGTABLET / ORALAB1997-10-22
A040197-002ESTRADIOLESTRADIOL1MGTABLET / ORALAB1997-10-22
A040197-003ESTRADIOLESTRADIOL2MGTABLET / ORALABRS1997-10-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040197-001AB
A040197-002AB
A040197-003AB

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 UTC2026-02A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-22d06236e962d9…
2024-10-29 15:01 UTC2024-10A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040197-002ESTRADIOL1MGTABLET / ORALAB1997-10-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040197-003ESTRADIOL2MGTABLET / ORALABRS1997-10-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040197-001ESTRADIOL0.5MGTABLET / ORALAB1997-10-228072bd15b7f6…

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 UTC2026-02A040197-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040197-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A040197-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040197-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040197-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040197-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040197-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040197-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A040197-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040197-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040197-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040197-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040197-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040197-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040197-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040197-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040197-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040197-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040197-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040197-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040197-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040197-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040197-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040197-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040197-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040197-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040197-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040197-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040197-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A040197-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040197-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040197-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040197-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040197-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040197-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040197-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040197-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040197-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040197-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040197-001AB18072bd15b7f6…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL1 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197657Internal RxNorm lookup
197658Internal RxNorm lookup
197659Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
80d6644a-d6f2-48e7-a685-92c4255b19feAvailable 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
71335-0445-1Estradiol100 in 1 BOTTLETABLET10017
71335-0445-2Estradiol30 in 1 BOTTLETABLET3017
71335-0445-3Estradiol90 in 1 BOTTLETABLET9017
71335-0445-4Estradiol60 in 1 BOTTLETABLET6017
71335-0445-5Estradiol180 in 1 BOTTLETABLET18017
71335-0445-6Estradiol120 in 1 BOTTLETABLET12017
71335-0445-7Estradiol28 in 1 BOTTLETABLET2817

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0445ESTRADIOL TABLET [BRYANT RANCH PREPACK]17Current NDC, Legacy NDC, 7 package rows20240522_80d6644a-d6f2-48e7-a685-92c4255b19fe.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 · 16 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLREMEDYREPACK INC.774ee81b-8e29-46af-ab12-7157f63b443b2026-06-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLNorthwind Health Company, LLCf6caf47a-1917-c493-e053-6394a90af63e2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLNorthwind Health Company, LLCf6cb38ab-fdff-9c07-e053-6294a90ad59a2026-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.f3a77482-f490-f350-e053-2a95a90ad8cb2025-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.c8ac2e13-58d5-4e70-e053-2995a90aff042025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLAmerican Health Packaging265a1ee1-f314-4324-a2e1-0120a9a00a202025-05-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLA-S Medication Solutions3e84e3e7-4b50-407f-a215-45363b5413842025-04-15Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLPD-Rx Pharmaceuticals, Inc.d0d1c2c8-b175-4250-9343-d7db65b72e8f2025-03-13Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLNuCare Pharmaceuticals,Inc.dd7d2d2a-e76b-7dfe-e053-2995a90a790a2025-02-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLPharmPak, Inc.20b50139-4e13-4f0c-aaf5-ecb83911d9e62025-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLProficient Rx LP7e570b07-2a9e-49bf-b224-1e34f6eda3ab2024-10-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLA-S Medication Solutions7f3c96ce-c855-4372-95ba-7759dd82bcca2024-07-18Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLBryant Ranch Prepack80d6644a-d6f2-48e7-a685-92c4255b19fe2024-04-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
ndc (product): 71335-0445
EstradiolESTRADIOLBryant Ranch Prepack414b846a-d6d9-4e8a-9632-12e296fc13c32024-04-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLTeva Pharmaceuticals USA, Inc.c4936878-1643-4e7f-9b0d-e4957935aef22024-02-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197
EstradiolESTRADIOLPharmPak, Inc.8f8c5a0b-4d7b-a5cb-e053-2995a90a494e2022-10-09Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040197
application number: ANDA040197

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197657estradiol 0.5 MG Oral TabletPSN80d6644a-d6f2-48e7-a685-92c4255b19fe17
197658estradiol 1 MG Oral TabletPSN80d6644a-d6f2-48e7-a685-92c4255b19fe17
197659estradiol 2 MG Oral TabletPSN80d6644a-d6f2-48e7-a685-92c4255b19fe17
197657estradiol 0.5 MG Oral TabletSCD80d6644a-d6f2-48e7-a685-92c4255b19fe17
197658estradiol 1 MG Oral TabletSCD80d6644a-d6f2-48e7-a685-92c4255b19fe17
197659estradiol 2 MG Oral TabletSCD80d6644a-d6f2-48e7-a685-92c4255b19fe17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0445-171335044501100 TABLET in 1 BOTTLE (71335-0445-1) 100 tablet2009-06-030000-00-00NoNoCurrent
71335-0445-27133504450230 TABLET in 1 BOTTLE (71335-0445-2) 30 tablet2009-06-030000-00-00NoNoCurrent
71335-0445-37133504450390 TABLET in 1 BOTTLE (71335-0445-3) 90 tablet2009-06-030000-00-00NoNoCurrent
71335-0445-47133504450460 TABLET in 1 BOTTLE (71335-0445-4) 60 tablet2009-06-030000-00-00NoNoCurrent
71335-0445-571335044505180 TABLET in 1 BOTTLE (71335-0445-5) 180 tablet2009-06-030000-00-00NoNoCurrent
71335-0445-671335044506120 TABLET in 1 BOTTLE (71335-0445-6) 120 tablet2009-06-030000-00-00NoNoCurrent
71335-0445-77133504450728 TABLET in 1 BOTTLE (71335-0445-7) 28 tablet2009-06-030000-00-00NoNoCurrent