Estring

Product NDC: 0013-1042
11-digit product format: 000131042
Labeler code: 0013
Product ID: 0013-1042_a7184faa-345a-46c5-82b5-badd9887a6e9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol
Dosage form: SYSTEM
Route: VAGINAL
Labeler: Pfizer Laboratories Div Pfizer Inc
Application: NDA020472
Marketing category: NDA
Marketing start: 2023-06-05
Substance: ESTRADIOL
Active strength: 2 mg/1
Pharmacologic classes: Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N020472-001	ESTRING	0.0075MG/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	1996-04-26	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Estring
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL	2 mg/1

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
848328	Internal RxNorm lookup
848330	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
110b9865-5a07-4d45-b560-e89947f12600	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
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1	Product name	1	20201123
85bed648-23ca-4804-98e6-e36aee999cad	Product name	1	20190717
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
80de93b4-8a94-428d-beb7-d644353ee70b	Product name	1	20180424
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688	Product name	1	20170522
db8eb201-78c7-4590-8a71-fac0a539bd8c	Product name	1	20170404
141092be-5eb5-452e-9f69-2d350aa70a87	Product name	1	20161208
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
0013-1042-01	Estring	1 in 1 POUCH	SYSTEM	1		7
0013-1042-01	Estring	1 in 1 CARTON	SYSTEM	1		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0013-1042-01	EA - Each	0013-1042	886a195e-fbf0-4016-938b-3785d1939b3e	1	2023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0013-1042	ESTRING (ESTRADIOL) SYSTEM [PFIZER LABORATORIES DIV PFIZER INC]	5	Current NDC, 2 package rows	20250523_110b9865-5a07-4d45-b560-e89947f12600.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 · 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 ndc (product): 0013-1042

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
848328	estradiol 2 MG (7.5 MCG per 24HR) 90 Day Vaginal System	PSN	110b9865-5a07-4d45-b560-e89947f12600	7
848330	Estring 2 MG (7.5 MCG per 24HR) 90 Day Vaginal System	PSN	110b9865-5a07-4d45-b560-e89947f12600	7
848330	90 DAY estradiol 0.000313 MG/HR Vaginal System [Estring]	SBD	110b9865-5a07-4d45-b560-e89947f12600	7
848328	90 DAY estradiol 0.000313 MG/HR Vaginal System	SCD	110b9865-5a07-4d45-b560-e89947f12600	7
848330	90 DAY Estring 0.000313 MG/24 HR Vaginal System	SY	110b9865-5a07-4d45-b560-e89947f12600	7
848330	90 DAY Estring 0.000313 MG/HR Vaginal System	SY	110b9865-5a07-4d45-b560-e89947f12600	7
848328	estradiol 0.000313 MG/HR 90 DAY Vaginal System	SY	110b9865-5a07-4d45-b560-e89947f12600	7
848328	estradiol 0.0075 MG/24 HR 90 DAY Vaginal System	SY	110b9865-5a07-4d45-b560-e89947f12600	7
848328	estradiol 7.5 MCG/24 HR 90 DAY Vaginal System	SY	110b9865-5a07-4d45-b560-e89947f12600	7
848330	Estring 0.0075 MG/24 HR 90 DAY Vaginal System	SY	110b9865-5a07-4d45-b560-e89947f12600	7
848330	Estring 7.5 MCG/24 HR 90 DAY Vaginal System	SY	110b9865-5a07-4d45-b560-e89947f12600	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0013-1042-01	00013104201	1 POUCH in 1 CARTON (0013-1042-01) / 1 SYSTEM in 1 POUCH	1 pouch	2023-06-05	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
ESTRING ® (estradiol vaginal system)	Pfizer Laboratories Div Pfizer Inc \| Pfizer Inc	2026-04-23	HUMAN PRESCRIPTION DRUG LABEL	7