Femring

Product NDC: 72495-201
11-digit product format: 724950201
Labeler code: 72495
Product ID: 72495-201_544b4b70-8164-4cf8-845b-23635bda46e7
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol acetate
Dosage form: RING
Route: VAGINAL
Labeler: Millicent US, Inc.
Application: NDA021367
Marketing category: NDA
Marketing start: 2018-12-10
Substance: ESTRADIOL ACETATE
Active strength: .05 mg/d
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 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N021367-001	FEMRING	ESTRADIOL ACETATE	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL		RLD	2003-03-20
N021367-002	FEMRING	ESTRADIOL ACETATE	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL		RLD, RS	2003-03-20

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`74a2ff9319b5…`

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: Femring
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL ACETATE	.05 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5R97F5H93P	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
848331	Internal RxNorm lookup
848333	Internal RxNorm lookup
848342	Internal RxNorm lookup
848343	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
7aaa97f9-a9d1-c815-e053-2991aa0afb9e	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
72495-201-05	Femring	1 in 1 CARTON	RING	1		7
72495-201-05	Femring	90 d in 1 POUCH	RING	90		7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72495-201-05	EA - Each	72495-201	6ff4b32b-a9c2-4797-bdd0-d45d8c9cd46f	1	2019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72495-201	FEMRING (ESTRADIOL ACETATE) RING [MILLICENT US, INC.]	6	Current NDC, Legacy NDC, 2 package rows	20240324_7aaa97f9-a9d1-c815-e053-2991aa0afb9e.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
Femring	ESTRADIOL ACETATE	Millicent US, Inc.	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	2025-12-09	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021367 application number: NDA021367 ndc (product): 72495-201

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5R97F5H93P	ESTRADIOL ACETATE	4245-41-4	ESTRADIOL ACETATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
848331	estradiol acetate 0.05 MG per 24HR 3 Month Vaginal System	PSN	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848342	estradiol acetate 0.1 MG per 24HR 3 Month Vaginal System	PSN	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848333	Femring 0.05 MG per 24HR 3 Month Vaginal System	PSN	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848343	Femring 0.1 MG per 24HR 3 Month Vaginal System	PSN	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848333	90 DAY estradiol 0.00208 MG/HR Vaginal System [Femring]	SBD	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848343	90 DAY estradiol 0.00417 MG/HR Vaginal System [Femring]	SBD	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848331	90 DAY estradiol 0.00208 MG/HR Vaginal System	SCD	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848342	90 DAY estradiol 0.00417 MG/HR Vaginal System	SCD	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848333	90 DAY Femring 0.00208 MG/HR Vaginal System	SY	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848343	90 DAY Femring 0.00417 MG/HR Vaginal System	SY	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848331	estradiol 0.05 MG per 24 HR Vaginal System, 90 Day	SY	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848342	estradiol 0.1 MG per 24 HR Vaginal System, 90 Day	SY	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848333	Femring 0.05 MG per 24HR 3 Month Vaginal System	SY	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848343	Femring 0.1 MG/24 HR 90 DAY Vaginal System	SY	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7
848343	Femring 100 MCG/24 HR 90 DAY Vaginal System	SY	7aaa97f9-a9d1-c815-e053-2991aa0afb9e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72495-201-05	72495020105	1 POUCH in 1 CARTON (72495-201-05) / 90 d in 1 POUCH	1 pouch	2018-12-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Femring - Millicent US, Inc. \| Millicent Pharma (NI) Limited	Millicent US, Inc. \| Millicent Pharma (NI) Limited	2025-12-09	HUMAN PRESCRIPTION DRUG LABEL	7