Estradiol

Product NDC: 50090-1343
11-digit product format: 500901343
Labeler code: 50090
Product ID: 50090-1343_f96aad7c-781c-47f5-894e-32a31f6c934c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: TABLET
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA040114
Marketing category: ANDA
Marketing start: 1996-03-14
Marketing end: 0000-00-00
Substance: ESTRADIOL
Active strength: 1 mg/1
Pharmacologic classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2019-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	50090-1343		I	Inactivated by FDA		2026-09-14
excluded package	package	50090-1343	50090-1343-0	I	Inactivated by FDA		2026-09-14

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 · 42 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50090-1343-0	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50090-1343-0	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50090-1343-0	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50090-1343-0	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50090-1343-0	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50090-1343-0	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	50090-1343-0	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	50090-1343-0	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	50090-1343-0	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	50090-1343-0	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	50090-1343-0	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-1343-0	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	50090-1343-0	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	50090-1343-0	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	50090-1343-0	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	50090-1343-0	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	50090-1343-0	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	50090-1343-0	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	50090-1343-0	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	50090-1343-0	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	50090-1343-0	`9bebd1f3094a…`	`5416666fcb17…`

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

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	Approval date
A040114-001	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14
A040114-002	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14
A040114-003	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14

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 4 · 129 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040114-002	ESTRADIOL	2MG	TABLET / ORAL	1996-03-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040114-003	ESTRADIOL	0.5MG	TABLET / ORAL	1996-03-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040114-001	ESTRADIOL	1MG	TABLET / ORAL	1996-03-14	`301d65b070ca…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A040114-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040114-002	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A040114-003	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A040114-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040114-002	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A040114-003	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A040114-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040114-002	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A040114-003	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040114-001	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040114-002	AB	1	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A040114-003	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A040114-001	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040114-002	AB	1	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	A040114-003	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A040114-001	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040114-002	AB	1	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	A040114-003	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A040114-001	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040114-002	AB	1	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	A040114-003	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A040114-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040114-002	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A040114-003	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A040114-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040114-002	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A040114-003	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A040114-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040114-002	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A040114-003	AB	1	`ea99ee380514…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-1343-0	2020-01-31	C162847	48780-1	9d75b9d0-c69a-f424-e053-dadaa90a57ce	Estradiol Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-1343-0	Estradiol	30 in 1 BOTTLE	TABLET	30		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-1343	ESTRADIOL TABLET [A-S MEDICATION SOLUTIONS]	5	Legacy NDC, 1 package rows	20171206_2b239796-ca18-4f54-a9b0-8002076c8e62.zip

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
197657	estradiol 0.5 MG Oral Tablet	PSN	2b239796-ca18-4f54-a9b0-8002076c8e62	5
197657	estradiol 0.5 MG Oral Tablet	SCD	2b239796-ca18-4f54-a9b0-8002076c8e62	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50090-1343-0	50090134300	30 in 1 BOTTLE	Historical