EstroGel

Product NDC: 17139-617
11-digit product format: 171390617
Labeler code: 17139
Product ID: 17139-617_54aba238-e71b-4933-a9ca-5fcaa6b8183a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: GEL, METERED
Route: TOPICAL
Labeler: ASCEND Therapeutics US, LLC
Application: NDA021166
Marketing category: NDA
Marketing start: 2004-02-09
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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	17139-617	17139-617-20	D	Discontinued by firm		2026-08-11
excluded package	package	17139-617	17139-617-43	D	Discontinued by firm		2026-08-11

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	17139-617-43	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	17139-617-20	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	17139-617-43	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	17139-617-20	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	17139-617-43	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	17139-617-20	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	17139-617-43	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	17139-617-20	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	17139-617-43	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	17139-617-20	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	17139-617-43	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	17139-617-20	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	17139-617-43	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	17139-617-20	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	17139-617-43	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	17139-617-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	17139-617-43	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	17139-617-20	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	17139-617-43	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	17139-617-20	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	17139-617-43	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	17139-617-20	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	17139-617-43	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	17139-617-20	`557ba5c1ecfa…`	`9c80585c8c6e…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021166-001	ESTROGEL	ESTRADIOL	0.06%	GEL / TOPICAL			2004-02-09
N021166-002	ESTROGEL	ESTRADIOL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021166-002	AB

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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL	AB	RLD, RS	2004-02-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2004-02-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2004-02-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2004-02-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2004-02-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2004-02-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021166-001	ESTROGEL	0.06%	GEL / TOPICAL			2004-02-09	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N021166-002	ESTROGEL	0.06% (1.25GM/ACTIVATION)	GEL, METERED / TRANSDERMAL		RLD, RS	2004-02-09	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021166-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021166-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021166-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021166-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021166-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021166-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021166-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021166-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021166-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021166-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021166-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021166-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021166-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021166-002	AB	1	`8072bd15b7f6…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021166-002	AB	1	`a50c72e98297…`

Additional Listing Data#

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

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4TI98Z838E	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
226597	Internal RxNorm lookup
581549	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
762ac371-bb8b-47e7-b48f-e80d452c9dd4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379	Product name	2	20250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6	Product name	2	20250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1	Product name	6	20250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbf	Product name	2	20250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1	Product name	3	20240507
66263a7f-f64d-41c4-90f1-2cee106617cc	Product name	1	20240501
76820076-f087-4073-b1d1-aa04b361335e	Product name	2	20220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94	Product name	3	20220126
0a040ba8-1f34-4328-bb07-4f64503daaab	Product name	2	20210513
833edb59-a012-45c2-aff5-2ed74b66fa59	Product name	1	20201207
f4d31098-441e-52d3-27f1-49c829f8a3a1	Product name	5	20190703
001f367b-fa14-49a0-865b-b395f2553601	Product name	2	20190611
3f090665-4687-4bb4-8790-8efb1930ee74	Product name	1	20180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4	Product name	1	20160623
3ca8d96e-517a-05ea-5690-f8e1d3726540	Product name	1	20140508
5f44c957-835a-ada0-662f-5b1071b7a68b	Product name	1	20140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183	Product name	1	20140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4	Product name	1	20140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4	Product name	1	20140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
17139-617-20	EstroGel	25 g in 1 BOTTLE, PUMP	GEL, METERED	25	54
17139-617-40	EstroGel	50 g in 1 BOTTLE, PUMP	GEL, METERED	50	54
17139-617-43	EstroGel	50 g in 1 BOTTLE, PUMP	GEL, METERED	50	54
17139-617-43	EstroGel	3 in 1 CARTON	GEL, METERED	3	54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
17139-617-40	GM - Gram	17139-617	2cfffdff-1b8a-4048-84a7-0fc42b22b4cb	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTROGEL (ESTRADIOL) GEL, METERED [ASCEND THERAPEUTICS US, LLC]	26
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTROGEL (ESTRADIOL) GEL, METERED [ASCEND THERAPEUTICS US, LLC]	26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
17139-617	ESTROGEL (ESTRADIOL) GEL, METERED [ASCEND THERAPEUTICS US, LLC]	51	Current NDC, Legacy NDC, 4 package rows	20240327_762ac371-bb8b-47e7-b48f-e80d452c9dd4.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EstroGel	ESTRADIOL	ASCEND Therapeutics US, LLC	762ac371-bb8b-47e7-b48f-e80d452c9dd4	2026-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021166 application number: NDA021166 ndc (product): 17139-617

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4TI98Z838E	ESTRADIOL	50-28-2	ESTRADIOL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
226597	estradiol 0.06 % Topical Gel	PSN	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55
581549	ESTROGel 0.06 % Topical Gel	PSN	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55
581549	estradiol 0.0006 MG/MG Topical Gel [Estrogel]	SBD	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55
226597	estradiol 0.0006 MG/MG Topical Gel	SCD	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55
226597	estradiol 0.06 % Topical Gel	SY	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55
581549	Estrogel 0.0006 MG/MG Topical Gel	SY	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55
581549	Estrogel 0.06 % Topical Gel	SY	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55
581549	Estrogel 0.75 MG per 1.25 GM Transdermal Gel	SY	762ac371-bb8b-47e7-b48f-e80d452c9dd4	55

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
17139-617-20	17139061720	25 g in 1 BOTTLE, PUMP	25 g					Historical
17139-617-40	17139061740	50 g in 1 BOTTLE, PUMP (17139-617-40)	50 g	2004-02-09	0000-00-00	No	No	Current
17139-617-43	17139061743	50 g in 1 BOTTLE, PUMP	50 g					Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
EstroGel	ASCEND Therapeutics US, LLC \| DPT Laboratories, Ltd.	2026-05-29	HUMAN PRESCRIPTION DRUG LABEL	55