ESTRADIOL VAGINAL

Product NDC: 21922-085
11-digit product format: 219220085
Labeler code: 21922
Product ID: 21922-085_1c61e837-4196-4b4d-9545-96b2d7c66f13
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: CREAM
Route: VAGINAL
Labeler: Encube Ethicals, Inc.
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: 2026-12-31
Current FDA listing: Yes

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

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 · 41 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
2026-02-19 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…`
2022-09-29 23:25 UTC	2022-09	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209767-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-03-05	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	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…`
2022-09-29 23:25 UTC	2022-09	A209767-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A209767-001	AB	1	`cb3db0bc1861…`

Additional Listing Data#

Finished product: Yes
Brand name base: ESTRADIOL VAGINAL
Listing expiration: 2026-12-31

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
1c61e837-4196-4b4d-9545-96b2d7c66f13	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	Strength	SPL version
21922-085-06	ESTRADIOL VAGINAL	1 in 1 CARTON	CREAM	1		1
21922-085-06	ESTRADIOL VAGINAL	42.5 g in 1 TUBE	CREAM	42.5		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21922-085-06	GM - Gram	21922-085	cdee0eb4-3ef0-4dd9-9ee2-d7d1dff1e067	1	2025-11-13

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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 ndc (product): 21922-085
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
310169	estradiol 0.01 % Vaginal Cream	PSN	1c61e837-4196-4b4d-9545-96b2d7c66f13	1
310169	estradiol 0.1 MG/ML Vaginal Cream	SCD	1c61e837-4196-4b4d-9545-96b2d7c66f13	1
310169	estradiol 0.01 % Vaginal Cream	SY	1c61e837-4196-4b4d-9545-96b2d7c66f13	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
21922-085-06	21922008506	1 TUBE in 1 CARTON (21922-085-06) / 42.5 g in 1 TUBE	1 tube	2025-08-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol Vaginal Cream, USP 0.01%	Encube Ethicals, Inc. \| Encube Ethicals Private Limited	2025-07-17	Human Prescription Drug Label	1