Estradiol

Product NDC: 50090-7611
11-digit product format: 500907611
Labeler code: 50090
Product ID: 50090-7611_55192761-40f5-4b70-9588-7784bf715148
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: A-S Medication Solutions
Application: ANDA075182
Marketing category: ANDA
Marketing start: 2000-03-01
Substance: ESTRADIOL
Active strength: .05 mg/d
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 43.

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A075182-001	ESTRADIOL	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24
A075182-002	ESTRADIOL	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26
A075182-003	ESTRADIOL	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26
A075182-004	ESTRADIOL	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20
A075182-005	ESTRADIOL	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20
A075182-006	ESTRADIOL	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 6 matching rows.

Application-product, TE code table
Application-product	TE code
A075182-001	AB2
A075182-002	AB2
A075182-003	AB2
A075182-004	AB2
A075182-005	AB2
A075182-006	AB2

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 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-005	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-006	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-001	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2000-02-24	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-002	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-003	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2005-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-004	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	2006-07-20	`b8a1b40f171c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 258 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075182-001	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-002	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-003	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-004	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-005	AB2	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A075182-006	AB2	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075182-001	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-002	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-003	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-004	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-005	AB2	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A075182-006	AB2	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075182-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A075182-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075182-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075182-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A075182-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075182-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075182-004	AB2	1	`b8a1b40f171c…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	.05 mg/d

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
238003	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
e962e36d-5d84-4b39-9bdf-e5f9a264b82a	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	Strength	SPL version
50090-7611-0	Estradiol	4 in 1 CARTON	PATCH	4		1
50090-7611-0	Estradiol	1 in 1 POUCH	PATCH	1		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-7611-0	EA - Each	50090-7611	f117b198-ae08-4a26-8543-594e6195017c	1	2025-08-11

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 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	A-S Medication Solutions	34bcec8e-c7a6-4a1c-9884-4d4efe024bb9	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	ba935918-39b3-4b56-bd83-78a29958e6d8	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	1c38f0d0-a360-4b66-bc0e-7d54e92465a1	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	eacafc4a-2fa8-403d-8df7-2bc92d73a54f	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	ee5460ab-27e7-487a-a89c-bf8735399be6	2026-06-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182
Estradiol	ESTRADIOL	A-S Medication Solutions	e962e36d-5d84-4b39-9bdf-e5f9a264b82a	2025-07-24	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182 ndc (product): 50090-7611
Estradiol	ESTRADIOL	Mylan Pharmaceuticals Inc.	e7e6da3b-8485-1382-61c9-e9b369018b98	2025-06-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075182 application number: ANDA075182

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
238003	estradiol 0.05 MG/Day Weekly Transdermal System	PSN	e962e36d-5d84-4b39-9bdf-e5f9a264b82a	1
238003	168 HR estradiol 0.00208 MG/HR Transdermal System	SCD	e962e36d-5d84-4b39-9bdf-e5f9a264b82a	1
238003	estradiol 0.05 MG/24HR Weekly Transdermal Patch	SY	e962e36d-5d84-4b39-9bdf-e5f9a264b82a	1
238003	estradiol 0.05 MG/Day Weekly Transdermal System	SY	e962e36d-5d84-4b39-9bdf-e5f9a264b82a	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
50090-7611-0	50090761100	4 POUCH in 1 CARTON (50090-7611-0) / 1 PATCH in 1 POUCH / 7 d in 1 PATCH	4 pouch	2025-07-22	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol - A-S Medication Solutions	A-S Medication Solutions	2025-07-24	HUMAN PRESCRIPTION DRUG LABEL	1