Estradiol Transdermal System

Product NDC: 47781-208
Requested package NDC: 47781-208-04
11-digit product format: 477810208
Labeler code: 47781
Product ID: 47781-208_1d1a1cca-2f54-d837-0c04-18a961c4405b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Alvogen, Inc.
Application: NDA020375
Marketing category: NDA
Marketing start: 2011-12-20
Marketing end: 2021-04-01
Substance: ESTRADIOL
Active strength: 0 mg/d
Pharmacologic classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	47781-208	47781-208-04	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 · 12 matching rows.

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

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

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

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	RLD / RS	Approval date
N020375-001	CLIMARA	ESTRADIOL	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22
N020375-002	CLIMARA	ESTRADIOL	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22
N020375-003	CLIMARA	ESTRADIOL	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23
N020375-004	CLIMARA	ESTRADIOL	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05
N020375-005	CLIMARA	ESTRADIOL	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27
N020375-006	CLIMARA	ESTRADIOL	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020375-001	AB2
N020375-002	AB2
N020375-003	AB2
N020375-004	AB2
N020375-005	AB2
N020375-006	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 · 246 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	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-005	CLIMARA	0.0375MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-006	CLIMARA	0.06MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	2003-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-001	CLIMARA	0.05MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1994-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-002	CLIMARA	0.1MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD, RS	1994-12-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-003	CLIMARA	0.075MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1998-03-23	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-004	CLIMARA	0.025MG/24HR	FILM, EXTENDED RELEASE / TRANSDERMAL	AB2	RLD	1999-03-05	`2680178bc6a6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 7 · 246 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020375-001	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-002	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-003	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-004	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-005	AB2	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020375-006	AB2	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-001	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-002	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-003	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-004	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-005	AB2	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020375-006	AB2	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020375-001	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-002	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-003	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-004	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-005	AB2	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020375-006	AB2	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-001	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-002	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-003	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-004	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-005	AB2	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020375-006	AB2	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-001	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-002	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-003	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-004	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-005	AB2	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020375-006	AB2	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-001	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-002	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-003	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-004	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-005	AB2	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020375-006	AB2	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-001	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-002	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-003	AB2	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020375-004	AB2	1	`2680178bc6a6…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
47781-208-04	EA - Each	47781-208	b7a01977-19ed-4c22-84bf-682c0e1787e9	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
ESTRADIOL	ACTIVE INGREDIENT	4TI98Z838E	ESTRADIOL TRANSDERMAL SYSTEM (ESTRADIOL) PATCH [ALVOGEN, INC.]	3
ESTRADIOL	ACTIVE MOIETY	4TI98Z838E	ESTRADIOL TRANSDERMAL SYSTEM (ESTRADIOL) PATCH [ALVOGEN, INC.]	3

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Climara	ESTRADIOL	Bayer HealthCare Pharmaceuticals Inc.	1e9702c4-f2d7-4ea8-b6e8-7dca31671864	2026-03-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020375 application number: NDA020375
Menostar	ESTRADIOL	Bayer HealthCare Pharmaceuticals Inc.	a78708cd-04d4-4221-a4e4-53680bbe2912	2026-03-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020375 application number: NDA020375
Estradiol Transdermal System	ESTRADIOL	Sandoz Inc	c714974b-766f-42f2-a846-b0c1f5a60560	2026-03-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 020375 application number: NDA020375

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
47781-208-04	47781020804	4 PATCH in 1 CARTON (47781-208-04) > 7 d in 1 PATCH	4 patch	2011-12-20	2021-04-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol - Alvogen, Inc. \| Bayer HealthCare Pharmaceuticals Inc.	Alvogen, Inc. \| Bayer HealthCare Pharmaceuticals Inc.	2020-01-29	HUMAN PRESCRIPTION DRUG LABEL	6