Estrace

Product NDC
0430-0722
Requested package NDC
0430-0722-24
11-digit product format
004300722
Labeler code
0430
Product ID
0430-0722_7d28252e-6605-4939-8d94-b2287d66fd98
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
TABLET
Route
ORAL
Labeler
Allergan, Inc.
Application
ANDA040197
Marketing category
ANDA
Marketing start
2011-12-26
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
2022-12-31
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 packagepackage0430-07220430-0722-24DDiscontinued by firm2026-08-03

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 · 1 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
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0430-07220430-0722-24DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0430-0722-24EA - Each0430-072276fedfc1-a2ca-48b2-a1f7-4be76a7acb8912012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ESTRADIOLACTIVE INGREDIENT4TI98Z838EESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
ESTRADIOLACTIVE MOIETY4TI98Z838EESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
D&C RED NO. 27INACTIVE INGREDIENT2LRS185U6KESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJESTRACE (ESTRADIOL) TABLET [WARNER CHILCOTT (US), LLC]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0430-0722ESTRACE (ESTRADIOL) TABLET [ALLERGAN, INC.]12Legacy NDC20240418_a3803ba3-4eee-4e2e-ac8c-821a4e6720cc.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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0430-0722-2400430072224100 TABLET in 1 BOTTLE (0430-0722-24) 100 tablet2011-12-260000-00-00NoNoCurrent