Application 021529

Type: NDA
Sponsor: ORGANON USA INC

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	IMPLANON	ETONOGESTREL	IMPLANT;IMPLANTATION	68MG/IMPLANT	No	No
002	NEXPLANON	ETONOGESTREL	IMPLANT;IMPLANTATION	68MG/IMPLANT	Yes	Yes

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

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
N021529-001	IMPLANON	ETONOGESTREL	68MG/IMPLANT	IMPLANT / IMPLANTATION			2006-07-17
N021529-002	NEXPLANON	ETONOGESTREL	68MG/IMPLANT	IMPLANT / IMPLANTATION		RLD, RS	2011-05-13

Orange Book patents#

Current patent rows page 1 of 1 · 5 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04
N021529-002	8888745	2026-08-28		Drug product	2014-12-03
N021529-002	10821277	2027-05-31		Drug product	2020-11-16
N021529-002	8722037	2027-09-28		Drug product	2014-05-15
N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N021529-002	D-199	2029-01-16

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 · 84 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	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021529-001	IMPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION		2006-07-17	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N021529-002	NEXPLANON	68MG/IMPLANT	IMPLANT / IMPLANTATION	RLD, RS	2011-05-31	`bb7c543d1eb4…`

Observed Orange Book patent history#

Patent history page 1 of 6 · 205 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-08-18 06:07:40	2026-07	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021529-001	9757552	2030-07-28	U-1	Drug product	2017-10-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021529-002	8888745	2026-08-28		Drug product	2014-12-03	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021529-002	10821277	2027-05-31		Drug product	2020-11-16	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021529-002	8722037	2027-09-28		Drug product	2014-05-15	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021529-002	9757552	2030-07-28	U-1	Drug product	2017-10-04	`2680178bc6a6…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N021529-002	D-199	2029-01-16	`caaa826d4ba7…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N021529-002	D-199	2029-01-16	`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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nexplanon	ETONOGESTREL	Organon LLC	487f8a62-e142-457c-97cc-2e398fde7594	2026-05-28	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021529 application number: NDA021529 ndc (product): 78206-145

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 11 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0052-0272	IMPLANON	etonogestrel	Organon USA Inc.	NDA	Current
0052-4330	Nexplanon	etonogestrel	Organon USA Inc.	NDA	Current
0052-4330	Nexplanon	etonogestrel	Organon USA Inc.	NDA	Current
0052-4330	Nexplanon	etonogestrel	Organon USA Inc.	NDA	Current
0052-4330	Nexplanon	etonogestrel	Organon USA Inc.	NDA	Current
0052-4330	Nexplanon	etonogestrel	Organon USA Inc.	NDA	Current
0052-4330	Nexplanon	etonogestrel	Organon USA Inc.	NDA	Current
0052-4330	Nexplanon	etonogestrel	Organon USA Inc.	NDA	Current
78206-145	Nexplanon	etonogestrel	Organon LLC	NDA	Current
78206-145	Nexplanon	etonogestrel	Organon LLC	NDA	Current
78206-145	Nexplanon	etonogestrel	Organon LLC	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84816	SUPPL	2026-01-22
84805	SUPPL	2026-01-22
75639	SUPPL	2023-10-30
75637	SUPPL	2023-10-30
75645	SUPPL	2023-10-03
75644	SUPPL	2023-10-03
75643	SUPPL	2023-10-03
75638	SUPPL	2023-10-02
72099	SUPPL	2022-09-16
72098	SUPPL	2022-09-16
72097	SUPPL	2022-09-16
72096	SUPPL	2022-09-16
72095	SUPPL	2022-09-16
71935	SUPPL	2022-08-26
64690	SUPPL	2020-09-25
64679	SUPPL	2020-09-25
64678	SUPPL	2020-09-25
58406	SUPPL	2019-04-25
58372	SUPPL	2019-04-24
48501	SUPPL	2017-05-23
48491	SUPPL	2017-05-23
28034	SUPPL	2016-03-16
37165	SUPPL	2016-03-15
5654	SUPPL	2015-08-21
15696	SUPPL	2015-08-20
37163	SUPPL	2014-07-09
37164	SUPPL	2013-10-01
28033	SUPPL	2013-10-01
37161	SUPPL	2012-02-06
5652	SUPPL	2012-02-03
5653	SUPPL	2011-05-19
37162	SUPPL	2011-05-16
42202	ORIG	2009-11-19
5651	SUPPL	2009-02-23
37160	SUPPL	2009-02-20
5650	SUPPL	2007-01-25
37159	ORIG	2006-07-21
28032	ORIG	2006-07-21