estradiol

Manufacturer: Zydus Lifesciences Limited
Effective date: 2023-04-21
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:54:33

Label at a glance#

Productestradiol

Active ingredientESTRADIOL

Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1400-4

Estradiol Transdermal System, USP

0.014 mg/day

Apply one transdermal system per week.

For Transdermal Use Only

Contents: 4 Transdermal Systems

Rx Only

zydus Pharmaceuticals USA

Estradiol Transdermal System USP 0.014 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
476545	estradiol 14 MCG/Day Weekly Transdermal System	PSN	1
476545	168 HR estradiol 0.000583 MG/HR Transdermal System	SCD	1
476545	estradiol 0.000583 MG/HR Weekly Transdermal Patch	SY	1
476545	estradiol 14 MCG/Day Weekly Transdermal Patch	SY	1
476545	estradiol 14 MCG/Day Weekly Transdermal System	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
ESTRADIOL Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

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
70771-1400-1	estradiol	7 d in 1 PATCH	PATCH	7	1
70771-1400-1	estradiol	1 in 1 POUCH	PATCH	1	1
70771-1400-4	estradiol	4 in 1 CARTON	PATCH	4	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70771-1400	ESTRADIOL PATCH [ZYDUS LIFESCIENCES LIMITED]	1	Current NDC, 3 package rows	20231102_2f2030c2-f72e-4142-9cff-540bc8fbf8a1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 9 matching rows.

estradiol
SILICON DIOXIDE
ETHYL OLEATE
ISOPROPYL MYRISTATE
GLYCERYL LAURATE
POVIDONE
2-ETHYLHEXYL ACRYLATE
2-HYDROXYETHYL ACRYLATE
GLYCIDYL METHACRYLATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
70771-1400	70771-1400-1, 70771-1400-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
ESTRADIOL	4TI98Z838E	ACTIB
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
ETHYL OLEATE	Z2Z439864Y	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
GLYCERYL LAURATE	Y98611C087	IACT
POVIDONE	FZ989GH94E	IACT
2-ETHYLHEXYL ACRYLATE	HR49R9S6XG	IACT
2-HYDROXYETHYL ACRYLATE	25GT92NY0C	IACT
GLYCIDYL METHACRYLATE	R8WN29J8VF	IACT

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A204379-001	ESTRADIOL	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB		2023-04-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204379-001	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.

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	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204379-001	ESTRADIOL	0.014MG/24HR	SYSTEM / TRANSDERMAL	AB	2023-04-17	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A204379-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A204379-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204379-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204379-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204379-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204379-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204379-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204379-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204379-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204379-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204379-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204379-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204379-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204379-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204379-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204379-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204379-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204379-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204379-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204379-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204379-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204379-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204379-001	AB	1	`3f0d92c62455…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A204379-001	AB	1	`a50c72e98297…`

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
estradiol	ESTRADIOL	Zydus Lifesciences Limited	2f2030c2-f72e-4142-9cff-540bc8fbf8a1	2023-04-21		Exact identifier ndc (package): 70771-1400-1 ndc (package): 70771-1400-4 ndc (product): 70771-1400 ndc11 (package): 70771140001 ndc11 (package): 70771140004 spl id: 7287c5b3-80de-4eab-9905-f597a4fbaf34 spl set id: 2f2030c2-f72e-4142-9cff-540bc8fbf8a1

Reported adverse events (FAERS/openFDA)#

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