Femring

Product NDC: 72495-302
Requested package NDC: 72495-302-10
11-digit product format: 724950302
Labeler code: 72495
Product ID: 72495-302_3a4fcf65-a9dc-4631-ae0b-5c7c91aba952
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: estradiol acetate
Dosage form: RING
Route: VAGINAL
Labeler: Millicent US, Inc.
Application: NDA021367
Marketing category: NDA
Marketing start: 2026-08-01
Substance: ESTRADIOL ACETATE
Active strength: .1 mg/d
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 44.

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 · 88 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-10-15 13:18:30	2026-09	N021367-001	FEMRING	EQ 0.05MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD	2003-03-20	`c2088c7a36db…`
2026-10-15 13:18:30	2026-09	N021367-002	FEMRING	EQ 0.1MG BASE/24HR	INSERT, EXTENDED RELEASE / VAGINAL	RLD, RS	2003-03-20	`c2088c7a36db…`
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…`

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: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ESTRADIOL ACETATE	.1 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

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	Sample	Exclude flag	Status
72495-302-10	72495030210	1 POUCH in 1 CARTON (72495-302-10) / 90 d in 1 POUCH	1 pouch	2026-08-01	Yes	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	2026-10-29	HUMAN PRESCRIPTION DRUG LABEL	8