ESTRACE

Product NDC: 50090-2321
Requested package NDC: 50090-2321-0
11-digit product format: 500902321
Labeler code: 50090
Product ID: 50090-2321_d0bdce5c-be19-4bfa-bc55-9682f516ea87
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: CREAM
Route: VAGINAL
Labeler: A-S Medication Solutions
Application: ANDA086069
Marketing category: ANDA
Marketing start: 2001-07-01
Substance: ESTRADIOL
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

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 · 1 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	50090-2321	50090-2321-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
A086069-001	ESTRACE	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A086069-001	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	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RS	1984-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086069-001	ESTRACE	0.01%	CREAM / VAGINAL	AB	RLD, RS	1984-01-31	`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	A086069-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A086069-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A086069-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A086069-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A086069-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A086069-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A086069-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A086069-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A086069-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A086069-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A086069-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A086069-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A086069-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A086069-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A086069-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A086069-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A086069-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A086069-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A086069-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A086069-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A086069-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A086069-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A086069-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A086069-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A086069-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A086069-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A086069-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A086069-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A086069-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A086069-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A086069-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A086069-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A086069-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A086069-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A086069-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A086069-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A086069-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A086069-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A086069-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A086069-001	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: ESTRACE
Listing expiration: 2026-12-31

Active Ingredients#

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

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
310169	Internal RxNorm lookup
890918	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
da52a602-f2a2-4382-be07-30351c58cc4b	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-2321-0	2023-02-07	C162847	48780-1	f386c649-eb79-0266-e053-dadaa90a7c1a	ESTRACE
50090-2321-0	2023-01-30	C162847	48780-1	f386c649-eb79-0266-e053-dadaa90a7c1a	ESTRACE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-2321-0	ESTRACE	1 in 1 CARTON	CREAM	1		20
50090-2321-0	ESTRACE	42.5 g in 1 TUBE	CREAM	42.5		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-2321-0	GM - Gram	50090-2321	fcde6453-e4ff-459d-aead-b5012dc817a4	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-2321	ESTRACE (ESTRADIOL) CREAM [A-S MEDICATION SOLUTIONS]	20	Current NDC, Legacy NDC, 2 package rows	20240813_da52a602-f2a2-4382-be07-30351c58cc4b.zip

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	A-S Medication Solutions	c8a2d29c-299c-4559-b859-87b303a4af81	2026-08-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086069 application number: ANDA086069
Estradiol	ESTRADIOL	Teva Pharmaceuticals USA, Inc.	c94738ff-dece-4fb6-bb44-4f8832a45f38	2025-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086069 application number: ANDA086069
ESTRACE	ESTRADIOL	A-S Medication Solutions	da52a602-f2a2-4382-be07-30351c58cc4b	2024-08-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086069 application number: ANDA086069 ndc (package): 50090-2321-0 ndc (product): 50090-2321 ndc11 (package): 50090232100
ESTRACE	ESTRADIOL	Allergan, Inc.	dfc41fcd-c5ba-4b25-b647-cf04d3988b3e	2024-05-29	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 086069 application number: ANDA086069

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
890918	ESTRACE 0.01 % Vaginal Cream	PSN	da52a602-f2a2-4382-be07-30351c58cc4b	20
310169	estradiol 0.01 % Vaginal Cream	PSN	da52a602-f2a2-4382-be07-30351c58cc4b	20
890918	estradiol 0.1 MG/ML Vaginal Cream [Estrace]	SBD	da52a602-f2a2-4382-be07-30351c58cc4b	20
310169	estradiol 0.1 MG/ML Vaginal Cream	SCD	da52a602-f2a2-4382-be07-30351c58cc4b	20
890918	Estrace 0.01 % Vaginal Cream	SY	da52a602-f2a2-4382-be07-30351c58cc4b	20
890918	Estrace 0.1 MG/ML Vaginal Cream	SY	da52a602-f2a2-4382-be07-30351c58cc4b	20
310169	estradiol 0.01 % Vaginal Cream	SY	da52a602-f2a2-4382-be07-30351c58cc4b	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-2321-0	50090232100	1 TUBE in 1 CARTON (50090-2321-0) / 42.5 g in 1 TUBE	1 tube	2016-03-02	0000-00-00	No	No	Current