Estring

Product NDC: 63539-021
Requested package NDC: 63539-021-01
11-digit product format: 635390021
Labeler code: 63539
Product ID: 63539-021_f7e98487-2a47-4677-aab2-8917972b2949
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: RING
Route: VAGINAL
Labeler: U.S. Pharmaceuticals
Application: NDA020472
Marketing category: NDA
Marketing start: 1996-04-26
Marketing end: 0000-00-00
Substance: ESTRADIOL
Active strength: 2 mg/1
Pharmacologic classes: Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA]
NDC exclude flag: No
Listing certified through: 2023-12-31
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	63539-021	63539-021-01	D	Discontinued by firm		2026-08-11

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 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
N020472-001	ESTRING	ESTRADIOL	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL		RLD, RS	1996-04-26

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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`cb3db0bc1861…`

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
estradiol	ACTIVE INGREDIENT	4TI98Z838E	ESTRING (ESTRADIOL) RING [U.S. PHARMACEUTICALS]	2
estradiol	ACTIVE MOIETY	4TI98Z838E	ESTRING (ESTRADIOL) RING [U.S. PHARMACEUTICALS]	2
barium sulfate	INACTIVE INGREDIENT	25BB7EKE2E	ESTRING (ESTRADIOL) RING [U.S. PHARMACEUTICALS]	2

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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Estring	ESTRADIOL	Pfizer Laboratories Div Pfizer Inc	110b9865-5a07-4d45-b560-e89947f12600	2026-04-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020472 application number: NDA020472

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
63539-021-01	63539002101	1 RING in 1 POUCH (63539-021-01)	1 ring	1996-04-26	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESTRING ® (estradiol vaginal ring)	U.S. Pharmaceuticals \| Pfizer Inc	2021-12-27	HUMAN PRESCRIPTION DRUG LABEL	7