Estradiol

Product NDC: 51862-332
11-digit product format: 518620332
Labeler code: 51862
Product ID: 51862-332_82bf095a-96f7-49e1-9946-53eb3cad9989
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: TABLET
Route: ORAL
Labeler: Mayne Pharma Inc.
Application: ANDA040197
Marketing category: ANDA
Marketing start: 2016-08-03
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: 2022-12-31
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	51862-332		D	Discontinued by firm		2026-08-03
excluded package	package	51862-332	51862-332-01	D	Discontinued by firm		2026-08-03

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 · 24 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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`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	51862-332-01	`557ba5c1ecfa…`	`9c80585c8c6e…`

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

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	TE codes	RLD / RS	Approval date
A040197-001	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22
A040197-002	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22
A040197-003	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-product	TE code
A040197-001	AB
A040197-002	AB
A040197-003	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.

Product history page 1 of 4 · 123 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	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-002	ESTRADIOL	1MG	TABLET / ORAL	AB		1997-10-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-003	ESTRADIOL	2MG	TABLET / ORAL	AB	RS	1997-10-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040197-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB		1997-10-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 4 · 123 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	A040197-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A040197-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A040197-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A040197-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A040197-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A040197-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A040197-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A040197-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A040197-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A040197-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A040197-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A040197-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A040197-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A040197-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-002	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A040197-003	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-002	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A040197-003	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A040197-001	AB	1	`8072bd15b7f6…`

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51862-332-01	EA - Each	51862-332	86bdc2b7-2b09-49cc-952c-b622232fb689	1	2016-09-02

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 · 16 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	REMEDYREPACK INC.	774ee81b-8e29-46af-ab12-7157f63b443b	2026-06-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6caf47a-1917-c493-e053-6394a90af63e	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Northwind Health Company, LLC	f6cb38ab-fdff-9c07-e053-6294a90ad59a	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	f3a77482-f490-f350-e053-2a95a90ad8cb	2025-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	c8ac2e13-58d5-4e70-e053-2995a90aff04	2025-09-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	American Health Packaging	265a1ee1-f314-4324-a2e1-0120a9a00a20	2025-05-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	A-S Medication Solutions	3e84e3e7-4b50-407f-a215-45363b541384	2025-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	d0d1c2c8-b175-4250-9343-d7db65b72e8f	2025-03-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	dd7d2d2a-e76b-7dfe-e053-2995a90a790a	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PharmPak, Inc.	20b50139-4e13-4f0c-aaf5-ecb83911d9e6	2025-01-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Proficient Rx LP	7e570b07-2a9e-49bf-b224-1e34f6eda3ab	2024-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	A-S Medication Solutions	7f3c96ce-c855-4372-95ba-7759dd82bcca	2024-07-18	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Bryant Ranch Prepack	80d6644a-d6f2-48e7-a685-92c4255b19fe	2024-04-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Bryant Ranch Prepack	414b846a-d6d9-4e8a-9632-12e296fc13c3	2024-04-04	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c4936878-1643-4e7f-9b0d-e4957935aef2	2024-02-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197
Estradiol	ESTRADIOL	PharmPak, Inc.	8f8c5a0b-4d7b-a5cb-e053-2995a90a494e	2022-10-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 040197 application number: ANDA040197

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	c5367945-a280-41bb-877c-fefccaa1806f	100
197657	estradiol 0.5 MG Oral Tablet	SCD	c5367945-a280-41bb-877c-fefccaa1806f	100

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
51862-332-01	51862033201	100 TABLET in 1 BOTTLE (51862-332-01)	100 tablet	2016-08-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol Tablets USP	Preferred Pharmaceuticals Inc.	2023-05-24	HUMAN PRESCRIPTION DRUG LABEL	3
Estradiol Tablets USP	Golden State Medical Supply, Inc.	2022-12-02	HUMAN PRESCRIPTION DRUG LABEL	5
Estradiol Tablets USP	Bryant Ranch Prepack	2021-10-21	HUMAN PRESCRIPTION DRUG LABEL	100
Estradiol Tablets USP	Mayne Pharma Inc.	2016-01-31	HUMAN PRESCRIPTION DRUG LABEL	7