estradiol

Product NDC: 68382-323
Requested package NDC: 68382-323-04
11-digit product format: 683820323
Labeler code: 68382
Product ID: 68382-323_1e54d575-0530-4304-8a50-3ffaf3c124d4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: PATCH
Route: TRANSDERMAL
Labeler: Zydus Pharmaceuticals USA Inc.
Application: ANDA204379
Marketing category: ANDA
Marketing start: 2023-11-02
Substance: ESTRADIOL
Active strength: .014 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 · 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…`

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	.014 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
476545	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
684850eb-d889-4370-a0a7-4a5c3113266a	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
68382-323-01	estradiol	1 in 1 POUCH	PATCH	1	2
68382-323-01	estradiol	7 d in 1 PATCH	PATCH	7	2
68382-323-04	estradiol	4 in 1 CARTON	PATCH	4	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68382-323	ESTRADIOL PATCH [ZYDUS PHARMACEUTICALS USA INC.]	2	Current NDC, 3 package rows	20240321_684850eb-d889-4370-a0a7-4a5c3113266a.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
estradiol	ESTRADIOL	Zydus Pharmaceuticals USA Inc.	684850eb-d889-4370-a0a7-4a5c3113266a	2024-03-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204379 application number: ANDA204379 ndc (package): 68382-323-04 ndc (product): 68382-323 ndc11 (package): 68382032304
estradiol	ESTRADIOL	Zydus Lifesciences Limited	2f2030c2-f72e-4142-9cff-540bc8fbf8a1	2023-04-21		Exact identifier application applno (ANDA): 204379 application number: ANDA204379

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
476545	estradiol 14 MCG/Day Weekly Transdermal System	PSN	684850eb-d889-4370-a0a7-4a5c3113266a	2
476545	168 HR estradiol 0.000583 MG/HR Transdermal System	SCD	684850eb-d889-4370-a0a7-4a5c3113266a	2
476545	estradiol 0.000583 MG/HR Weekly Transdermal Patch	SY	684850eb-d889-4370-a0a7-4a5c3113266a	2
476545	estradiol 14 MCG/Day Weekly Transdermal Patch	SY	684850eb-d889-4370-a0a7-4a5c3113266a	2
476545	estradiol 14 MCG/Day Weekly Transdermal System	SY	684850eb-d889-4370-a0a7-4a5c3113266a	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
68382-323-04	68382032304	4 POUCH in 1 CARTON (68382-323-04) / 1 PATCH in 1 POUCH (68382-323-01) / 7 d in 1 PATCH	4 pouch	2023-11-02	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
estradiol - Zydus Pharmaceuticals USA Inc. \| ZYDUS NOVELTECH INC, USA \| Zydus Lifesciences Limited	Zydus Pharmaceuticals USA Inc. \| ZYDUS NOVELTECH INC, USA \| Zydus Lifesciences Limited	2024-03-20	HUMAN PRESCRIPTION DRUG LABEL	2