Estradiol

Product NDC: 67296-2279
Requested package NDC: 67296-2279-9
11-digit product format: 672962279
Labeler code: 67296
Product ID: 67296-2279_5718eadd-60b8-d96c-e063-6394a90a31c1
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: TABLET
Route: ORAL
Labeler: Redpharm Drug
Application: ANDA217334
Marketing category: ANDA
Marketing start: 2024-07-10
Substance: ESTRADIOL
Active strength: 1 mg/1
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	Approval date
A217334-001	ESTRADIOL	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06
A217334-002	ESTRADIOL	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06
A217334-003	ESTRADIOL	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A217334-001	AB
A217334-002	AB
A217334-003	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 2 · 66 observed 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	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-002	ESTRADIOL	1MG	TABLET / ORAL	AB	2023-09-06	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-003	ESTRADIOL	2MG	TABLET / ORAL	AB	2023-09-06	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-001	ESTRADIOL	0.5MG	TABLET / ORAL	AB	2023-09-06	`301d65b070ca…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 66 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A217334-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217334-002	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A217334-003	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A217334-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217334-002	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A217334-003	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A217334-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-002	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A217334-003	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-002	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A217334-003	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A217334-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-002	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A217334-003	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-002	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A217334-003	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-002	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A217334-003	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-002	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A217334-003	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-002	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A217334-003	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-002	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A217334-003	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-002	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A217334-003	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A217334-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-002	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A217334-003	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-002	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A217334-003	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A217334-001	AB	1	`301d65b070ca…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	1 mg/1

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
197658	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
5718f042-e8c0-b721-e063-6294a90a5bef	Available on FDA.report

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 · 19 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol	ESTRADIOL	Redpharm Drug	5718f042-e8c0-b721-e063-6294a90a5bef	2026-07-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334 ndc (package): 67296-2279-9 ndc (product): 67296-2279 ndc11 (package): 67296227909
Estradiol	ESTRADIOL	REMEDYREPACK INC.	41f7a56c-4ce3-4cc6-803e-1ff662efef90	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	REMEDYREPACK INC.	59a4b68d-a507-4809-a0c8-fd9799986d12	2026-06-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Preferred Pharmaceuticals, Inc.	6d129a94-8ecd-40a3-9a95-c5e1ece41ab1	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Direct_Rx	47e446f8-ac16-ea6b-e063-6394a90a1726	2026-01-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Northwind Health Company, LLC	106b92da-334c-542f-e063-6394a90aa65b	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Northwind Health Company, LLC	0a1e744c-7926-0e0c-e063-6294a90a80d0	2026-01-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	NorthStar Rx LLC	1c2cd11a-e010-20b2-e063-6294a90a52d5	2025-11-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Bryant Ranch Prepack	ff3bcb07-f6fe-4582-948a-21dbf1e55f55	2025-10-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Coupler LLC	37c99e4d-fb0d-0e6e-e063-6394a90a69c8	2025-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Preferred Pharmaceuticals Inc.	72fbd5a8-9c34-4790-84ed-79f5bd3ae0f0	2025-04-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	PD-Rx Pharmaceuticals, Inc.	aa396e57-0a93-49cc-82e5-cd35c987bb0b	2025-02-20	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	A-S Medication Solutions	f7e8dd35-c12f-46be-96f9-bf9a9b6f9a90	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	A-S Medication Solutions	41f424ec-9d08-4fda-b21d-41e92da6e1f0	2024-12-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	230c2eda-b0f1-d9ec-e063-6394a90a603c	2024-09-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Bryant Ranch Prepack	5e9bd73f-67db-44f9-a5ee-409eed765cd2	2024-09-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	Bryant Ranch Prepack	9eb88585-4994-474f-bd63-c4e003bf6f20	2024-07-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	NuCare Pharmaceuticals,Inc.	1bbdb10b-9a32-3899-e063-6294a90ab26d	2024-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334
Estradiol	ESTRADIOL	ANI Pharmaceuticals, Inc.	3fe899db-a8cd-4a31-88fb-1129be96b4d9	2024-04-15	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 217334 application number: ANDA217334

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	Sample	Exclude flag	Status
67296-2279-9	67296227909	90 TABLET in 1 BOTTLE (67296-2279-9)	90 tablet	2024-07-10	No	No	Current