Application 213051

Type: NDA
Sponsor: NOVO

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RYBELSUS	SEMAGLUTIDE	TABLET;ORAL	3MG	Yes	No
002	RYBELSUS	SEMAGLUTIDE	TABLET;ORAL	7MG	Yes	No
003	RYBELSUS	SEMAGLUTIDE	TABLET;ORAL	14MG	Yes	Yes
004	OZEMPIC	SEMAGLUTIDE	TABLET;ORAL	1.5MG	Yes	Yes
005	OZEMPIC	SEMAGLUTIDE	TABLET;ORAL	4MG	Yes	Yes
006	OZEMPIC	SEMAGLUTIDE	TABLET;ORAL	9MG	Yes	Yes

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

Orange Book products#

Current product rows page 1 of 1 · 6 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N213051-001	RYBELSUS	SEMAGLUTIDE	3MG	TABLET / ORAL	RLD, RS	2019-09-20
N213051-002	RYBELSUS	SEMAGLUTIDE	7MG	TABLET / ORAL	RLD, RS	2019-09-20
N213051-003	RYBELSUS	SEMAGLUTIDE	14MG	TABLET / ORAL	RLD, RS	2019-09-20
N213051-004	OZEMPIC	SEMAGLUTIDE	1.5MG	TABLET / ORAL	RLD, RS	2024-12-09
N213051-005	OZEMPIC	SEMAGLUTIDE	4MG	TABLET / ORAL	RLD, RS	2024-12-09
N213051-006	OZEMPIC	SEMAGLUTIDE	9MG	TABLET / ORAL	RLD, RS	2024-12-09

Orange Book patents#

Current patent rows page 1 of 1 · 73 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N213051-001	8536122	2026-03-20	U-2628	Drug substance, Drug product	2019-10-15
N213051-001	8129343	2031-12-05	U-2628	Drug substance, Drug product	2019-10-15
N213051-001	10086047	2031-12-16		Drug product	2019-10-15
N213051-001	10960052	2031-12-16		Drug product	2021-04-26
N213051-001	11382957	2031-12-16		Drug product	2022-07-26
N213051-001	9278123	2031-12-16	U-2628	Drug product	2019-10-15
N213051-001	10933120	2033-03-15		Drug product	2021-03-31
N213051-001	11759501	2033-03-15		Drug product	2023-10-12
N213051-001	11759502	2033-03-15		Drug product	2023-10-12
N213051-001	11759503	2033-03-15		Drug product	2023-10-12
N213051-001	12594326	2033-03-15		Drug product	2026-04-20
N213051-001	11033499	2033-06-19	U-2628	Drug product	2026-05-07
N213051-001	10278923	2034-05-02	U-2628		2019-10-15
N213051-001	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06
N213051-001	12514822	2034-05-02	U-2628		2026-01-14
N213051-002	8536122	2026-03-20	U-2628	Drug substance, Drug product	2019-10-15
N213051-002	8129343	2031-12-05	U-2628	Drug substance, Drug product	2019-10-15
N213051-002	10086047	2031-12-16		Drug product	2019-10-15
N213051-002	10960052	2031-12-16		Drug product	2021-04-26
N213051-002	11382957	2031-12-16		Drug product	2022-07-26
N213051-002	9278123	2031-12-16	U-2628	Drug product	2019-10-15
N213051-002	10933120	2033-03-15		Drug product	2021-03-31
N213051-002	11759501	2033-03-15		Drug product	2023-10-12
N213051-002	11759502	2033-03-15		Drug product	2023-10-12
N213051-002	11759503	2033-03-15		Drug product	2023-10-12
N213051-002	12594326	2033-03-15		Drug product	2026-04-20
N213051-002	11033499	2033-06-19	U-2628	Drug product	2026-05-07
N213051-002	10278923	2034-05-02	U-2628		2019-10-15
N213051-002	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06
N213051-002	12514822	2034-05-02	U-2628		2026-01-14
N213051-003	8536122	2026-03-20	U-2628	Drug substance, Drug product	2019-10-15
N213051-003	8129343	2031-12-05	U-2628	Drug substance, Drug product	2019-10-15
N213051-003	10086047	2031-12-16		Drug product	2019-10-15
N213051-003	10960052	2031-12-16		Drug product	2021-04-26
N213051-003	11382957	2031-12-16		Drug product	2022-07-26
N213051-003	9278123	2031-12-16	U-2628	Drug product	2019-10-15
N213051-003	10933120	2033-03-15		Drug product	2021-03-31
N213051-003	11759501	2033-03-15		Drug product	2023-10-12
N213051-003	11759502	2033-03-15		Drug product	2023-10-12
N213051-003	11759503	2033-03-15		Drug product	2023-10-12
N213051-003	12594326	2033-03-15		Drug product	2026-04-20
N213051-003	11033499	2033-06-19	U-2628	Drug product	2026-05-07
N213051-003	10278923	2034-05-02	U-2628		2019-10-15
N213051-003	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06
N213051-003	12514822	2034-05-02	U-2628		2026-01-14
N213051-004	8536122	2026-03-20	U-2628	Drug substance, Drug product	2025-05-06
N213051-004	8129343	2031-12-05	U-2628	Drug substance, Drug product	2025-05-06
N213051-004	11382957	2031-12-16		Drug substance, Drug product	2025-02-21
N213051-004	11033499	2033-06-19	U-2628	Drug product	2026-05-07
N213051-004	10278923	2034-05-02	U-2628	Drug substance, Drug product	2025-02-21
N213051-004	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06
N213051-004	12514822	2034-05-02	U-2628		2026-01-14
N213051-004	11833248	2039-02-01	U-2628	Drug product	2025-01-07
N213051-004	12396953	2039-02-01	U-2628	Drug product	2025-09-03
N213051-005	8536122	2026-03-20	U-2628	Drug substance, Drug product	2025-05-06
N213051-005	8129343	2031-12-05	U-2628	Drug substance, Drug product	2025-05-06
N213051-005	11382957	2031-12-16		Drug substance, Drug product	2025-02-21
N213051-005	11033499	2033-06-19	U-2628	Drug product	2026-05-07
N213051-005	10278923	2034-05-02	U-2628	Drug substance, Drug product	2025-02-21
N213051-005	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06
N213051-005	12514822	2034-05-02	U-2628		2026-01-14
N213051-005	11833248	2039-02-01	U-2628	Drug product	2025-01-07
N213051-005	12396953	2039-02-01	U-2628	Drug product	2025-09-03
N213051-006	8536122	2026-03-20	U-2628	Drug substance, Drug product	2025-05-06
N213051-006	8129343	2031-12-05	U-2628	Drug substance, Drug product	2025-05-06
N213051-006	11382957	2031-12-16		Drug substance, Drug product	2025-02-21
N213051-006	9278123	2031-12-16	U-2628	Drug substance, Drug product	2025-02-21
N213051-006	11033499	2033-06-19	U-2628	Drug product	2026-05-07
N213051-006	10278923	2034-05-02	U-2628	Drug substance, Drug product	2025-02-21
N213051-006	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06
N213051-006	12514822	2034-05-02	U-2628		2026-01-14
N213051-006	11833248	2039-02-01	U-2628	Drug product	2025-01-07
N213051-006	12396953	2039-02-01	U-2628	Drug product	2025-09-03

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 6 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N213051-001	I-976	2028-10-17
N213051-002	I-976	2028-10-17
N213051-003	I-976	2028-10-17
N213051-004	I-976	2028-10-17
N213051-005	I-976	2028-10-17
N213051-006	I-976	2028-10-17

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 4 · 144 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	N213051-001	RYBELSUS	3MG	TABLET / ORAL	RLD, RS	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	RYBELSUS	7MG	TABLET / ORAL	RLD, RS	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	RYBELSUS	14MG	TABLET / ORAL	RLD, RS	2019-09-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-004	OZEMPIC	1.5MG	TABLET / ORAL	RLD, RS	2024-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-005	OZEMPIC	4MG	TABLET / ORAL	RLD, RS	2024-12-09	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-006	OZEMPIC	9MG	TABLET / ORAL	RLD, RS	2024-12-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213051-001	RYBELSUS	3MG	TABLET / ORAL	RLD, RS	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-002	RYBELSUS	7MG	TABLET / ORAL	RLD, RS	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-003	RYBELSUS	14MG	TABLET / ORAL	RLD, RS	2019-09-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-004	RYBELSUS	1.5MG	TABLET / ORAL	RLD, RS	2024-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-005	RYBELSUS	4MG	TABLET / ORAL	RLD, RS	2024-12-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-006	RYBELSUS	9MG	TABLET / ORAL	RLD, RS	2024-12-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-001	RYBELSUS	3MG	TABLET / ORAL	RLD, RS	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-002	RYBELSUS	7MG	TABLET / ORAL	RLD, RS	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-003	RYBELSUS	14MG	TABLET / ORAL	RLD, RS	2019-09-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-004	RYBELSUS	1.5MG	TABLET / ORAL	RLD, RS	2024-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-005	RYBELSUS	4MG	TABLET / ORAL	RLD, RS	2024-12-09	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-006	RYBELSUS	9MG	TABLET / ORAL	RLD, RS	2024-12-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N213051-001	RYBELSUS	3MG	TABLET / ORAL	RLD, RS	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213051-002	RYBELSUS	7MG	TABLET / ORAL	RLD, RS	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213051-003	RYBELSUS	14MG	TABLET / ORAL	RLD, RS	2019-09-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213051-004	RYBELSUS	1.5MG	TABLET / ORAL	RLD	2024-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213051-005	RYBELSUS	4MG	TABLET / ORAL	RLD	2024-12-09	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N213051-006	RYBELSUS	9MG	TABLET / ORAL	RLD, RS	2024-12-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213051-001	RYBELSUS	3MG	TABLET / ORAL	RLD, RS	2019-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213051-002	RYBELSUS	7MG	TABLET / ORAL	RLD, RS	2019-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213051-003	RYBELSUS	14MG	TABLET / ORAL	RLD, RS	2019-09-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213051-004	RYBELSUS	1.5MG	TABLET / ORAL	RLD	2024-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213051-005	RYBELSUS	4MG	TABLET / ORAL	RLD	2024-12-09	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N213051-006	RYBELSUS	9MG	TABLET / ORAL	RLD, RS	2024-12-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213051-001	RYBELSUS	3MG	TABLET / ORAL	RLD, RS	2019-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213051-002	RYBELSUS	7MG	TABLET / ORAL	RLD, RS	2019-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213051-003	RYBELSUS	14MG	TABLET / ORAL	RLD, RS	2019-09-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213051-004	RYBELSUS	1.5MG	TABLET / ORAL	RLD	2024-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213051-005	RYBELSUS	4MG	TABLET / ORAL	RLD	2024-12-09	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N213051-006	RYBELSUS	9MG	TABLET / ORAL	RLD, RS	2024-12-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213051-001	RYBELSUS	3MG	TABLET / ORAL	RLD, RS	2019-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213051-002	RYBELSUS	7MG	TABLET / ORAL	RLD, RS	2019-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213051-003	RYBELSUS	14MG	TABLET / ORAL	RLD, RS	2019-09-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N213051-004	RYBELSUS	1.5MG	TABLET / ORAL	RLD	2024-12-09	`03ed91905a0d…`

Observed Orange Book patent history#

Patent history page 1 of 32 · 1,254 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	N213051-001	8536122	2026-03-20	U-2628	Drug substance, Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	8129343	2031-12-05	U-2628	Drug substance, Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	10086047	2031-12-16		Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	10960052	2031-12-16		Drug product	2021-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	11382957	2031-12-16		Drug product	2022-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	9278123	2031-12-16	U-2628	Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	10933120	2033-03-15		Drug product	2021-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	11759501	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	11759502	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	11759503	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	12594326	2033-03-15		Drug product	2026-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	11033499	2033-06-19	U-2628	Drug product	2026-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	10278923	2034-05-02	U-2628		2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-001	12514822	2034-05-02	U-2628		2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	8536122	2026-03-20	U-2628	Drug substance, Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	8129343	2031-12-05	U-2628	Drug substance, Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	10086047	2031-12-16		Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	10960052	2031-12-16		Drug product	2021-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	11382957	2031-12-16		Drug product	2022-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	9278123	2031-12-16	U-2628	Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	10933120	2033-03-15		Drug product	2021-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	11759501	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	11759502	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	11759503	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	12594326	2033-03-15		Drug product	2026-04-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	11033499	2033-06-19	U-2628	Drug product	2026-05-07	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	10278923	2034-05-02	U-2628		2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	12239739	2034-05-02	U-2628	Drug substance, Drug product	2025-05-06	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	12514822	2034-05-02	U-2628		2026-01-14	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	8536122	2026-03-20	U-2628	Drug substance, Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	8129343	2031-12-05	U-2628	Drug substance, Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	10086047	2031-12-16		Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	10960052	2031-12-16		Drug product	2021-04-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	11382957	2031-12-16		Drug product	2022-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	9278123	2031-12-16	U-2628	Drug product	2019-10-15	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	10933120	2033-03-15		Drug product	2021-03-31	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	11759501	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	11759502	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	11759503	2033-03-15		Drug product	2023-10-12	`caaa826d4ba7…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 5 · 180 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-08-18 06:07:40	2026-07	N213051-001	I-976	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-002	I-976	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-003	I-976	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-004	I-976	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-005	I-976	2028-10-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N213051-006	I-976	2028-10-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N213051-001	I-976	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-002	I-976	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-003	I-976	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-004	I-976	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-005	I-976	2028-10-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N213051-006	I-976	2028-10-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-001	I-976	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-002	I-976	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-003	I-976	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-004	I-976	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-005	I-976	2028-10-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N213051-006	I-976	2028-10-17	`31067a03dcf5…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-001	NP	2022-09-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-001	NCE	2022-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-001	M-252	2023-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-002	NP	2022-09-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-002	NCE	2022-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-002	M-252	2023-01-16	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-003	NP	2022-09-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-003	NCE	2022-12-05	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N213051-003	M-252	2023-01-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N213051-001	NP	2022-09-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-001	NCE	2022-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-001	M-252	2023-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-002	NP	2022-09-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-002	NCE	2022-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-002	M-252	2023-01-16	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-003	NP	2022-09-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-003	NCE	2022-12-05	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N213051-003	M-252	2023-01-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N213051-001	NP	2022-09-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213051-001	NCE	2022-12-05	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213051-001	M-252	2023-01-16	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N213051-002	NP	2022-09-20	`4b0b4de00fa7…`

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
OZEMPIC	ORAL SEMAGLUTIDE	Novo Nordisk Pharmaceutical Industries, LP	27f15fac-7d98-4114-a2ec-92494a91da98	2026-01-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 213051 application number: NDA213051 ndc (product): 0169-4303 ndc (product): 0169-4314 ndc (product): 0169-4307

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 18 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0169-4303	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4303	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4303	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4303	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4303	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4303	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4307	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4307	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4307	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4307	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4307	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4307	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4314	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4314	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4314	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4314	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4314	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current
0169-4314	RYBELSUS	Oral Semaglutide	Novo Nordisk	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
84949	SUPPL	2026-02-05
84895	SUPPL	2026-02-03
83857	SUPPL	2025-10-21
83856	SUPPL	2025-10-21
83855	SUPPL	2025-10-21
83854	SUPPL	2025-10-21
83832	SUPPL	2025-10-20
83830	SUPPL	2025-10-20
83829	SUPPL	2025-10-20
83828	SUPPL	2025-10-20
80546	SUPPL	2025-02-11
80545	SUPPL	2025-02-11
80551	SUPPL	2024-12-10
80550	SUPPL	2024-12-10
80140	SUPPL	2024-11-05
80128	SUPPL	2024-11-05
77299	SUPPL	2024-01-25
77291	SUPPL	2024-01-25
73158	SUPPL	2023-01-13
73157	SUPPL	2023-01-13
73152	SUPPL	2023-01-13
71305	SUPPL	2022-06-14
71297	SUPPL	2022-06-14
71296	SUPPL	2022-06-14
67413	SUPPL	2021-05-05
67412	SUPPL	2021-05-05
63478	ORIG	2020-06-10
61603	SUPPL	2020-01-17
61592	SUPPL	2020-01-17
61591	SUPPL	2020-01-17
60094	ORIG	2019-09-24
60078	ORIG	2019-09-20
60077	ORIG	2019-09-20