ESTRADIOL VAGINAL

Product NDC: 67296-2303
Requested package NDC: 67296-2303-4
11-digit product format: 672962303
Labeler code: 67296
Product ID: 67296-2303_58beabb8-6903-b26a-e063-6294a90a67f8
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: CREAM
Route: VAGINAL
Labeler: Redpharm Drug
Application: ANDA209767
Marketing category: ANDA
Marketing start: 2025-08-14
Substance: ESTRADIOL HEMIHYDRATE
Active strength: .1 mg/g
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A209767-001	ESTRADIOL	ESTRADIOL	0.01%	CREAM / VAGINAL	AB		2018-03-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A209767-001	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.

Product history page 1 of 2 · 43 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	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 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	A209767-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A209767-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A209767-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A209767-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A209767-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A209767-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A209767-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A209767-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A209767-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A209767-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A209767-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A209767-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A209767-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A209767-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A209767-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A209767-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A209767-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A209767-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A209767-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A209767-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A209767-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A209767-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A209767-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A209767-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A209767-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A209767-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A209767-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A209767-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A209767-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A209767-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A209767-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A209767-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A209767-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A209767-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A209767-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A209767-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A209767-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A209767-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A209767-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A209767-001	AB	1	`f41ea6bd6efb…`

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 VAGINAL
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL HEMIHYDRATE	.1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
CXY7B3Q98Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310169	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
58beabb8-6902-b26a-e063-6294a90a67f8	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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ESTRADIOL VAGINAL	ESTRADIOL	Redpharm Drug	58beabb8-6902-b26a-e063-6294a90a67f8	2026-08-11	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767 ndc (package): 67296-2303-4 ndc (product): 67296-2303 ndc11 (package): 67296230304
Estradiol	ESTRADIOL	Alvogen Inc.	0178a92c-62b1-d5cf-cf54-2c85af88a74a	2025-11-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767
ESTRADIOL VAGINAL	ESTRADIOL	Encube Ethicals, Inc.	1c61e837-4196-4b4d-9545-96b2d7c66f13	2025-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767
Estradiol	ESTRADIOL	Bryant Ranch Prepack	74baff07-15df-48a8-93b8-3a317f896a56	2024-08-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767
Estradiol	ESTRADIOL	A-S Medication Solutions	31646359-292c-4bca-88a4-7a89b11c3f44	2023-12-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 209767 application number: ANDA209767

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
CXY7B3Q98Z	ESTRADIOL HEMIHYDRATE	35380-71-3	ESTRADIOL HEMIHYDRATE
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
67296-2303-4	67296230304	1 TUBE in 1 CARTON (67296-2303-4) / 42.5 g in 1 TUBE	1 tube	2025-08-14	No	No	Current