Estradiol

Product NDC
54348-701
11-digit product format
543480701
Labeler code
54348
Product ID
54348-701_2bd95a2b-6eee-e171-e063-6394a90a4e4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ESTRADIOL
Dosage form
TABLET
Route
ORAL
Labeler
PharmPak, Inc.
Application
ANDA040197
Marketing category
ANDA
Marketing start
2019-07-09
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

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct54348-701UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage54348-70154348-701-30UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
20b50139-4e13-4f0c-aaf5-ecb83911d9e6Available 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
54348-701-30Estradiol1 in 1 BOXTABLET13
54348-701-30Estradiol30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54348-701ESTRADIOL TABLET [PHARMPAK, INC.]3Current NDC, Legacy NDC, 2 package rows20250119_20b50139-4e13-4f0c-aaf5-ecb83911d9e6.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
ndc (product): 54348-701
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
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
197658estradiol 1 MG Oral TabletPSN20b50139-4e13-4f0c-aaf5-ecb83911d9e63
197658estradiol 1 MG Oral TabletSCD20b50139-4e13-4f0c-aaf5-ecb83911d9e63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54348-701-30543480701301 BOTTLE in 1 BOX (54348-701-30) / 30 TABLET in 1 BOTTLE1 bottle2019-07-090000-00-00NoNoCurrent