FDA.reportPublic FDA data

Estradiol

Product NDC
73473-308
11-digit product format
734730308
Labeler code
73473
Product ID
73473-308_83acb69b-859c-47f7-9e4b-fe349d0e0aa6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Estradiol
Dosage form
GEL
Route
TOPICAL
Labeler
Solaris Pharma Corporation
Application
ANDA216160
Marketing category
ANDA
Marketing start
2026-01-28
Substance
ESTRADIOL
Active strength
.75 mg/1.25g
Pharmacologic classes
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A216160-001ESTRADIOLESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A216160-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-228072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216160-001ESTRADIOL0.06% (1.25GM/ACTIVATION)GEL, METERED / TRANSDERMALAB2024-04-22a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A216160-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A216160-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A216160-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A216160-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A216160-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216160-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216160-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216160-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216160-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216160-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216160-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216160-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216160-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216160-001AB18072bd15b7f6…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A216160-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A216160-001CGT2024-10-2303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A216160-001CGT2024-10-232680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A216160-001CGT2024-10-235bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A216160-001CGT2024-10-23d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A216160-001CGT2024-10-23d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A216160-001CGT2024-10-2379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A216160-001CGT2024-10-23301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A216160-001CGT2024-10-231e350fbaab3a…
2024-05-31 18:47 UTC2024-05A216160-001CGT2024-10-238072bd15b7f6…

Additional Listing Data#

Finished product
Yes
Brand name base
Estradiol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ESTRADIOL.75 mg/1.25g

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
226597Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67e8665c-5331-423c-99fd-546ab6cccb07Available 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
73473-308-50Estradiol1 in 1 CARTONGEL19
73473-308-50Estradiol50 g in 1 BOTTLE, PUMPGEL509

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73473-308-50GM - Gram73473-3082d408515-3971-41c0-ab9b-4bc7424b7dc912024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73473-308ESTRADIOL GEL [SOLARIS PHARMA CORPORATION]8Current NDC, 2 package rows20250319_67e8665c-5331-423c-99fd-546ab6cccb07.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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EstradiolESTRADIOLSolaris Pharma Corporation67e8665c-5331-423c-99fd-546ab6cccb072026-01-26Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 216160
application number: ANDA216160
ndc (product): 73473-308

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
226597estradiol 0.06 % Topical GelPSN67e8665c-5331-423c-99fd-546ab6cccb079
226597estradiol 0.0006 MG/MG Topical GelSCD67e8665c-5331-423c-99fd-546ab6cccb079
226597estradiol 0.06 % Topical GelSY67e8665c-5331-423c-99fd-546ab6cccb079

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73473-308-50734730308501 BOTTLE, PUMP in 1 CARTON (73473-308-50) / 50 g in 1 BOTTLE, PUMP2026-01-28NoNoCurrent