Etonogestrel/Ethinyl Estradiol

Product NDC: 50090-5959
11-digit product format: 500905959
Labeler code: 50090
Product ID: 50090-5959_74985d3b-59fe-491b-bf40-962faa0274ab
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etonogestrel and ethinyl estradiol
Dosage form: INSERT, EXTENDED RELEASE
Route: VAGINAL
Labeler: A-S Medication Solutions
Application: NDA021187
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2021-06-01
Substance: ETHINYL ESTRADIOL; ETONOGESTREL
Active strength: .015; .12 mg/d; mg/d
Pharmacologic classes: Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [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 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
N021187-001	NUVARING	ETHINYL ESTRADIOL; ETONOGESTREL	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N021187-001	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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL		RLD, RS	2001-10-03	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL		RLD, RS	2001-10-03	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL		RLD, RS	2001-10-03	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021187-001	NUVARING	0.015MG/24HR;0.12MG/24HR	RING / VAGINAL	AB	RLD, RS	2001-10-03	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021187-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021187-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021187-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021187-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021187-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021187-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021187-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021187-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021187-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021187-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021187-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021187-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021187-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021187-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021187-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021187-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021187-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N021187-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021187-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021187-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021187-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021187-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021187-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021187-001	AB	1	`3f01610625f2…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021187-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021187-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021187-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021187-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021187-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021187-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021187-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021187-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021187-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021187-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021187-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021187-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021187-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021187-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Etonogestrel/Ethinyl Estradiol
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ETONOGESTREL	.015 mg/d
ETHINYL ESTRADIOL	.12 mg/d

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
304GTH6RNH	Internal UNII lookup
423D2T571U	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
fcf9da2a-bb91-4697-bfaa-c9d58855e275	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d1ecea64-06d1-4fdc-a2a1-b801e0cd0d11	Product name	4	20250623
d39a542a-f5b0-4c2d-a820-0f5d39e6621f	Product name	1	20250307
8511fc19-172b-4e1f-90ec-2f09c85b16de	Product name	2	20250116
d9a998ac-31a9-4391-9054-c30e50912603	Product name	2	20240829
782f1593-b73e-4d35-8017-647969d714d8	Product name	4	20240805
1a545a57-aed5-4b6e-b1f9-a93c26d50eff	Product name	1	20230829
a0f93f28-4e91-4bb1-8dcb-5456fd4bfc50	Product name	3	20230718
a057e1a7-94b1-4663-8d17-a3bbf3a12689	Product name	5	20230627
0d9f32e2-f85b-4d63-9f04-b06059c34749	Product name	3	20230323
fa479cfe-0bd0-7366-d57a-92f3682e87c5	Product name	3	20210518
20e1a411-dba8-4afa-b9f9-1205d5b0bde9	Product name	3	20210513
cec4644c-0fed-4608-a5ea-d3a1b1b6d697	Product name	2	20200728
00a01e22-7ea3-6f8f-0cc1-380aac10f424	Product name	6	20200716
5956a0e2-c373-452c-bdcf-c93d354432ef	Product name	1	20200714
ca306105-d51c-4821-9ec1-8eec753d073d	Product name	1	20200619
f1d1b304-0b6c-25e9-a872-86d3d4bd2ab9	Product name	8	20200612
0381745d-0d4c-bcc1-87eb-abb98c1e6cb6	Product name	8	20191120
6dd982ab-2966-22ee-3b75-d225abb791aa	Product name	5	20190612
d2c4820a-bb24-f61d-8cd0-dd0290a6bd4d	Product name	7	20190612
f92411e4-13dd-7baf-106e-9b3fcf758c39	Product name	4	20190502
60ff9adc-7870-42ca-8836-514bd9732fa8	Product name	4	20181220
ddff2484-d547-4e6a-bacd-95eef7e31c64	Product name	2	20180807
c6636356-4ccb-40e9-a952-59eb1f2fc859	Product name	4	20180806
79d5025d-8129-440a-b861-6df2d2661609	Product name	3	20180607
e042bc86-5d40-8945-82f8-de9dd95420dd	Product name	6	20180606
d871c48c-6b0b-4203-b55d-72ead21ea7ad	Product name	5	20180419
90854981-3820-4bc4-a1d3-666ec508941c	Product name	2	20180214
390e6d23-3a11-4327-9294-c958a378baae	Product name	4	20180124
12434b90-2738-45d5-9e1b-55001e853273	Product name	2	20171122
b651f154-0364-4007-9dc6-9d33036db1d7	Product name	4	20170808
3395ac9b-f30b-4991-80ba-fd5196be0214	Product name	3	20170802
2d386545-84d1-e1e9-1402-7fc8962353e8	Product name	2	20170717
a5e2d962-d98c-4fbf-8183-ffd42dd01e19	Product name	6	20170711
30783b73-16b0-4cc1-b03a-e5d801c0d7a8	Product name	4	20170608
00606b81-6e33-4c38-9ca9-bd14bd74d84c	Product name	4	20170501
f4ce24e8-8632-4fad-9984-b693f985f80f	Product name	3	20170501
b17c5419-b38b-579f-10bc-8a4ce69fc044	Product name	5	20170316
120cc5ad-761c-444c-9e82-dec22f96dfe1	Product name	7	20161219
01996782-abcb-4e6d-bcaf-4a23e6a95c0c	Product name	1	20160714
2aecf0b6-88a0-49e5-92e1-983c700c116c	Product name	1	20151222
61972742-5d4d-491d-a881-b6bc3a011577	Product name	1	20151113
5e13e814-349e-3480-99f3-ee22a591426f	Product name	2	20150518
03fd8ce8-4166-aad3-3bb9-c26530b16888	Product name	1	20140508
63e5a7e1-a373-7c98-ef5d-a8a5e0a755b3	Product name	1	20140508
d0cc7d42-77a7-b452-c6c3-a162fa11225f	Product name	1	20140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-5959-0	EA - Each	50090-5959	205dab34-b033-4c77-8907-40edcab3647e	1	2024-03-12

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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NuvaRing	ETONOGESTREL AND ETHINYL ESTRADIOL	Organon LLC	55eb60e3-6f4d-40a3-8ee6-e7fd2d0c7d97	2025-11-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021187 application number: NDA021187
NUVARING	ETONOGESTREL AND ETHINYL ESTRADIOL	A-S Medication Solutions	524c7188-ee84-4d5c-a6ab-e7a5ae36e22b	2025-10-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021187 application number: NDA021187
NuvaRing	ETONOGESTREL AND ETHINYL ESTRADIOL	Advanz Pharma (US) Corp.	19ef66d1-913f-49a8-a0a5-59b4e20322f5	2025-03-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021187 application number: NDA021187
Etonogestrel/Ethinyl Estradiol	ETONOGESTREL AND ETHINYL ESTRADIOL	Prasco Laboratories	f0d80e01-f4f5-4b1a-bc9e-50a2bd4390b1	2025-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021187 application number: NDA021187
NUVARING	ETONOGESTREL AND ETHINYL ESTRADIOL	A-S Medication Solutions	e14bc197-dd22-4e6e-8aa1-d6cf2242fe0f	2024-03-10	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021187 application number: NDA021187
Etonogestrel/Ethinyl Estradiol	ETONOGESTREL AND ETHINYL ESTRADIOL	A-S Medication Solutions	fcf9da2a-bb91-4697-bfaa-c9d58855e275	2023-11-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021187 application number: NDA021187 ndc (product): 50090-5959

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
423D2T571U	ETHINYL ESTRADIOL	57-63-6	ETHINYL ESTRADIOL
304GTH6RNH	ETONOGESTREL	54048-10-1	ETONOGESTREL

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-5959-0	50090595900	1 POUCH in 1 BOX (50090-5959-0) / 1 d in 1 POUCH	1 pouch	2022-04-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etonogestrel/Ethinyl Estradiol - A-S Medication Solutions	A-S Medication Solutions	2023-11-22	HUMAN PRESCRIPTION DRUG LABEL	4