Estradiol Vaginal Cream

Product NDC: 66993-002
11-digit product format: 669930002
Labeler code: 66993
Product ID: 66993-002_b871564a-2980-4404-a9f5-f52e3f3cecd6
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: CREAM
Route: VAGINAL
Labeler: Prasco Laboratories
Application: ANDA212313
Marketing category: ANDA
Marketing start: 2021-10-01
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

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
A212313-001	ESTRADIOL	ESTRADIOL	0.01%	CREAM / VAGINAL	AB		2021-07-15

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A212313-001	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.

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	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212313-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2021-07-15	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A212313-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A212313-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A212313-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A212313-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A212313-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A212313-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A212313-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A212313-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A212313-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A212313-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A212313-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A212313-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A212313-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A212313-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A212313-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A212313-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A212313-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A212313-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A212313-001	AB	1	`782e0a99824c…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A212313-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A212313-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A212313-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A212313-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A212313-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A212313-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A212313-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A212313-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A212313-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A212313-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A212313-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A212313-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A212313-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A212313-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Estradiol Vaginal Cream
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 · 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
c895ac14-5dbd-4201-bf3e-ba7c38a4e994	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
66993-002-10	Estradiol Vaginal Cream	42.5 g in 1 TUBE	CREAM	42.5		11
66993-002-10	Estradiol Vaginal Cream	1 in 1 CARTON	CREAM	1		11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-002-10	GM - Gram	66993-002	e70ab68b-38d7-4814-bd9b-ff11bf8dbf5c	1	2021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-002	ESTRADIOL VAGINAL CREAM (ESTRADIOL) CREAM [PRASCO LABORATORIES]	8	Current NDC, Legacy NDC, 2 package rows	20240301_c895ac14-5dbd-4201-bf3e-ba7c38a4e994.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol Vaginal	ESTRADIOL	A-S Medication Solutions	e5dbfeff-188f-4991-b2b7-f5f03987f7fb	2025-01-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212313 application number: ANDA212313
Estradiol Vaginal Cream	ESTRADIOL	Prasco Laboratories	c895ac14-5dbd-4201-bf3e-ba7c38a4e994	2024-03-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 212313 application number: ANDA212313 ndc (product): 66993-002

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
310169	estradiol 0.01 % Vaginal Cream	PSN	c895ac14-5dbd-4201-bf3e-ba7c38a4e994	11
310169	estradiol 0.1 MG/ML Vaginal Cream	SCD	c895ac14-5dbd-4201-bf3e-ba7c38a4e994	11
310169	estradiol 0.01 % Vaginal Cream	SY	c895ac14-5dbd-4201-bf3e-ba7c38a4e994	11
310169	estradiol 0.01 % Vaginal Cream	PSN	e5dbfeff-188f-4991-b2b7-f5f03987f7fb	3
310169	estradiol 0.1 MG/ML Vaginal Cream	SCD	e5dbfeff-188f-4991-b2b7-f5f03987f7fb	3
310169	estradiol 0.01 % Vaginal Cream	SY	e5dbfeff-188f-4991-b2b7-f5f03987f7fb	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
66993-002-10	66993000210	1 TUBE in 1 CARTON (66993-002-10) / 42.5 g in 1 TUBE	1 tube	2021-10-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol Vaginal Cream , USP , 0.01%	A-S Medication Solutions	2025-01-09	HUMAN PRESCRIPTION DRUG LABEL	3
Estradiol Vaginal Cream , USP , 0.01%	Prasco Laboratories	2024-03-25	HUMAN PRESCRIPTION DRUG LABEL	11