Application 021187

Type: NDA
Sponsor: ORGANON SUB MERCK

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NUVARING	ETHINYL ESTRADIOL; ETONOGESTREL	RING;VAGINAL	0.015MG/24HR;0.12MG/24HR	Yes	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…`

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 ndc (product): 78206-146
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 ndc (product): 66993-605
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 ndc (product): 50090-5611
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

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 20 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0052-0273	NuvaRing	etonogestrel and ethinyl estradiol	Organon USA Inc.	NDA	Current
0052-0273	NuvaRing	etonogestrel and ethinyl estradiol	Organon USA Inc.	NDA	Current
0052-0273	NuvaRing	etonogestrel and ethinyl estradiol	Organon USA Inc.	NDA	Current
50090-1008	NUVARING	etonogestrel and ethinyl estradiol	A-S Medication Solutions	NDA	Current
50090-1008	NUVARING	etonogestrel and ethinyl estradiol	A-S Medication Solutions	NDA	Current
50090-5611	NUVARING	etonogestrel and ethinyl estradiol	A-S Medication Solutions	NDA	Current
50090-5959	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	A-S Medication Solutions	NDA AUTHORIZED GENERIC	Current
66993-605	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-605	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-605	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-605	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-605	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-605	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
66993-605	Etonogestrel/Ethinyl Estradiol	etonogestrel and ethinyl estradiol	Prasco Laboratories	NDA AUTHORIZED GENERIC	Current
76413-131	NuvaRing	etonogestrel and ethinyl estradiol	Central Texas Community Health Centers	NDA	Current
78206-146	NuvaRing	etonogestrel and ethinyl estradiol	Organon LLC	NDA	Current
78206-146	NuvaRing	etonogestrel and ethinyl estradiol	Organon LLC	NDA	Current
78206-146	NuvaRing	etonogestrel and ethinyl estradiol	Organon LLC	NDA	Current
78206-146	NuvaRing	etonogestrel and ethinyl estradiol	Organon LLC	NDA	Current
78206-146	NuvaRing	etonogestrel and ethinyl estradiol	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
78624	SUPPL	2024-06-04
78611	SUPPL	2024-06-03
70933	SUPPL	2022-05-03
70902	SUPPL	2022-05-02
58693	SUPPL	2019-05-14
58660	SUPPL	2019-05-13
56653	SUPPL	2018-12-07
56652	SUPPL	2018-12-07
56636	SUPPL	2018-12-06
56635	SUPPL	2018-12-06
52768	SUPPL	2018-02-28
52639	SUPPL	2018-02-14
52626	SUPPL	2018-02-14
49374	SUPPL	2017-08-15
49308	SUPPL	2017-08-10
48626	SUPPL	2017-06-02
48613	SUPPL	2017-06-01
45583	SUPPL	2016-10-06
45470	SUPPL	2016-10-04
21498	SUPPL	2015-04-06
42012	SUPPL	2015-03-10
44639	SUPPL	2015-01-09
24186	SUPPL	2015-01-09
14610	SUPPL	2014-11-07
27025	SUPPL	2014-11-03
14609	SUPPL	2014-06-23
4602	SUPPL	2014-06-19
4601	SUPPL	2013-10-21
4600	SUPPL	2013-10-21
36316	SUPPL	2013-10-08
14608	SUPPL	2013-10-08
4599	SUPPL	2008-05-05
27024	SUPPL	2007-10-04
14607	SUPPL	2007-10-04
36315	SUPPL	2005-08-03
27023	SUPPL	2005-08-03
4598	SUPPL	2004-03-10
4597	SUPPL	2004-03-02
42011	ORIG	2001-10-03
36314	ORIG	2001-10-03
4596	ORIG	2001-10-03