Estradiol Vaginal

Product NDC: 0115-1518
Requested package NDC: 0115-1518-66
11-digit product format: 001151518
Labeler code: 0115
Product ID: 0115-1518_af097442-3a07-4842-901d-151d63951f15
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Estradiol
Dosage form: CREAM
Route: VAGINAL
Labeler: Amneal Pharmaceuticals of New York LLC
Application: ANDA210194
Marketing category: ANDA
Marketing start: 2018-03-14
Marketing end: 2022-12-31
Substance: ESTRADIOL
Active strength: 0 mg/g
Pharmacologic classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0115-1518	0115-1518-66	D	Discontinued by firm		2026-09-14

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`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
A210194-001	ESTRADIOL	ESTRADIOL	0.01%	CREAM / VAGINAL	AB		2018-01-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A210194-001	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	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210194-001	ESTRADIOL	0.01%	CREAM / VAGINAL	AB	2018-01-22	`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	A210194-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A210194-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A210194-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A210194-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A210194-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A210194-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A210194-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A210194-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A210194-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A210194-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A210194-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A210194-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A210194-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A210194-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A210194-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A210194-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A210194-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A210194-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A210194-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A210194-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A210194-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A210194-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A210194-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A210194-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A210194-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A210194-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A210194-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A210194-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A210194-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A210194-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A210194-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A210194-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A210194-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A210194-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A210194-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A210194-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A210194-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A210194-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A210194-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A210194-001	AB	1	`f41ea6bd6efb…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0115-1518-66	2021-12-08	C162847	48780-1	ba0f9c33-45e7-a910-e053-dadaa90a0b85	Estradiol Vaginal Cream USP, 0.01%
0115-1518-66	2021-01-29	C162847	48780-1	ba0f9c33-45e7-a910-e053-dadaa90a0b85	Estradiol Vaginal Cream USP, 0.01%

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0115-1518-66	GM - Gram	0115-1518	9c9a4d57-25af-46f3-94c6-76fa042c5a92	1	2018-05-09

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estradiol Vaginal	ESTRADIOL	Redpharm Drug	546c168d-2a85-69b6-e063-6294a90a22ac	2026-06-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	A-S Medication Solutions	0137d491-6917-4060-9b32-e0cd7b0badbb	2026-04-13	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	67f581cb-6d77-49fc-b2f3-976e3b57dcbf	2026-03-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	AvKARE	bb7b442d-b8c3-b7f0-e053-2a95a90a2c94	2026-01-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Padagis Israel Pharmaceuticals Ltd	f76232ed-b109-43d1-bf2e-d41b6420c37d	2025-10-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	f3806b5d-ebd6-43b4-adfa-a1fe86d80642	2025-10-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	NuCare Pharmaceuticals, Inc.	2e5a4d78-6683-4fb8-e063-6294a90a49e7	2025-02-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194
Estradiol Vaginal	ESTRADIOL	Bryant Ranch Prepack	e7b15ec3-e195-44a6-bdd7-9b6de2b235b8	2024-07-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 210194 application number: ANDA210194

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	Marketing end	Sample	Exclude flag	Status
0115-1518-66	00115151866	1 TUBE in 1 CARTON (0115-1518-66) > 42.5 g in 1 TUBE	1 tube	2018-03-14	2022-12-31	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Estradiol Vaginal Cream USP, 0.01%	Amneal Pharmaceuticals of New York LLC	2021-11-16	HUMAN PRESCRIPTION DRUG LABEL	4