WEGOVY

Product NDC: 0169-4501
11-digit product format: 001694501
Labeler code: 0169
Product ID: 0169-4501_2cf550fd-3019-4202-b112-2009de398600
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: semaglutide
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Novo Nordisk Pharmaceutical Industries, LP
Application: NDA215256
Marketing category: NDA
Marketing start: 2021-06-05
Substance: SEMAGLUTIDE
Active strength: 1 mg/.5mL
Pharmacologic classes: GLP-1 Receptor Agonist [EPC], Glucagon-Like Peptide 1 [CS], Glucagon-like Peptide-1 (GLP-1) Agonists [MoA]
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 1.

Orange Book products#

Current product rows page 1 of 1 · 12 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N215256-001	WEGOVY	SEMAGLUTIDE	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-002	WEGOVY	SEMAGLUTIDE	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-003	WEGOVY	SEMAGLUTIDE	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-004	WEGOVY	SEMAGLUTIDE	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-005	WEGOVY	SEMAGLUTIDE	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04
N215256-006	WEGOVY HD	SEMAGLUTIDE	7.2MG/0.75ML (7.2MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-03-19
N215256-007	WEGOVY	SEMAGLUTIDE	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-008	WEGOVY	SEMAGLUTIDE	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-009	WEGOVY	SEMAGLUTIDE	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-010	WEGOVY	SEMAGLUTIDE	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-011	WEGOVY	SEMAGLUTIDE	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-05-05
N215256-012	WEGOVY FLEXTOUCH	SEMAGLUTIDE	9.6MG/3ML (3.2MG/ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2026-06-18

Orange Book patents#

Current patent rows page 1 of 2 · 110 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N215256-001	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-001	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-001	9764003	2033-06-21	U-3161		2021-06-30
N215256-001	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-001	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-001	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-001	11478533	2040-05-13	U-3861		2025-09-03
N215256-001	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-002	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-002	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-002	9764003	2033-06-21	U-3161		2021-06-30
N215256-002	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-002	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-002	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-002	11478533	2040-05-13	U-3861		2025-09-03
N215256-002	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-003	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-003	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-003	9764003	2033-06-21	U-3161		2021-06-30
N215256-003	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-003	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-003	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-003	11478533	2040-05-13	U-3861		2025-09-03
N215256-003	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-004	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-004	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-004	9764003	2033-06-21	U-3161		2021-06-30
N215256-004	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-004	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-004	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-004	11478533	2040-05-13	U-3861		2025-09-03
N215256-004	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-005	8536122	2026-03-20		Drug substance, Drug product	2021-06-30
N215256-005	8129343	2031-12-05		Drug substance, Drug product	2021-06-30
N215256-005	9764003	2033-06-21	U-3161		2021-06-30
N215256-005	10888605	2038-08-24	U-3162	Drug product	2021-06-30
N215256-005	11752198	2038-08-24	U-3162	Drug product	2023-10-10
N215256-005	12214017	2038-08-24	U-3162	Drug product	2025-03-06
N215256-005	12029779	2038-10-10	U-3162		2024-07-09
N215256-005	12551536	2038-10-10	U-4418		2026-03-02
N215256-005	11478533	2040-05-13	U-3861		2025-09-03
N215256-005	11318191	2041-02-17	U-3162	Drug product	2022-06-29
N215256-006	8129343	2031-12-05		Drug substance, Drug product	2026-03-31
N215256-006	9764003	2033-06-21	U-4418		2026-03-31
N215256-006	10888605	2038-08-24	U-4418	Drug product	2026-03-31
N215256-006	11752198	2038-08-24	U-4418	Drug product	2026-03-31
N215256-006	12214017	2038-08-24	U-4418	Drug product	2026-03-31
N215256-006	12029779	2038-10-10	U-4418		2026-03-31
N215256-006	12551536	2038-10-10	U-4418		2026-03-31
N215256-006	11318191	2041-02-17	U-4418	Drug product	2026-03-31
N215256-007	8129343	2031-12-05		Drug substance, Drug product	2026-06-23
N215256-007	9764003	2033-06-21	U-3161		2026-06-23
N215256-007	12569543	2037-04-28	U-4443		2026-06-23
N215256-007	10888605	2038-08-24	U-3162	Drug product	2026-06-23
N215256-007	11752198	2038-08-24	U-3162	Drug product	2026-06-23
N215256-007	12214017	2038-08-24	U-3162	Drug product	2026-06-23
N215256-007	12029779	2038-10-10	U-3162		2026-06-23
N215256-007	12551536	2038-10-10	U-4418		2026-06-23
N215256-007	11478533	2040-05-13	U-3861		2026-06-23
N215256-007	11318191	2041-02-17	U-3162	Drug product	2026-06-23
N215256-007	11318191	2041-02-17	U-4443	Drug product	2026-06-23
N215256-007	11318191	2041-02-17	U-4560	Drug product	2026-06-23
N215256-008	8129343	2031-12-05		Drug substance, Drug product	2026-06-23
N215256-008	9764003	2033-06-21	U-3161		2026-06-23
N215256-008	12569543	2037-04-28	U-4443		2026-06-23
N215256-008	10888605	2038-08-24	U-3162	Drug product	2026-06-23
N215256-008	11752198	2038-08-24	U-3162	Drug product	2026-06-23
N215256-008	12214017	2038-08-24	U-3162	Drug product	2026-06-23
N215256-008	12029779	2038-10-10	U-3162		2026-06-23
N215256-008	12551536	2038-10-10	U-4418		2026-06-23
N215256-008	11478533	2040-05-13	U-3861		2026-06-23
N215256-008	11318191	2041-02-17	U-3162	Drug product	2026-06-23
N215256-008	11318191	2041-02-17	U-4443	Drug product	2026-06-23
N215256-008	11318191	2041-02-17	U-4560	Drug product	2026-06-23
N215256-009	8129343	2031-12-05		Drug substance, Drug product	2026-06-23
N215256-009	9764003	2033-06-21	U-3161		2026-06-23
N215256-009	12569543	2037-04-28	U-4443		2026-06-23
N215256-009	10888605	2038-08-24	U-3162	Drug product	2026-06-23
N215256-009	11752198	2038-08-24	U-3162	Drug product	2026-06-23
N215256-009	12214017	2038-08-24	U-3162	Drug product	2026-06-23

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 12 matching rows.

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N215256-001	I-935	2027-03-08
N215256-001	I-973	2028-08-15
N215256-002	I-935	2027-03-08
N215256-002	I-973	2028-08-15
N215256-003	I-935	2027-03-08
N215256-003	I-973	2028-08-15
N215256-004	D-190	2026-07-21
N215256-004	I-935	2027-03-08
N215256-004	I-973	2028-08-15
N215256-005	I-935	2027-03-08
N215256-005	I-973	2028-08-15
N215256-006	NS	2029-03-19

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 5 · 172 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-001	WEGOVY	0.25MG/0.5ML (0.25MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-002	WEGOVY	0.5MG/0.5ML (0.5MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-003	WEGOVY	1MG/0.5ML (1MG/0.5ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-004	WEGOVY	1.7MG/0.75ML (1.7MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N215256-005	WEGOVY	2.4MG/0.75ML (2.4MG/0.75ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-06-04	`5bbf6a4d5a75…`

Observed Orange Book patent history#

Patent history page 1 of 26 · 1,022 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Submission date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215256-001	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	11318191	2041-02-17	U-3162	Drug product	2022-06-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	8536122	2026-03-20		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	8129343	2031-12-05		Drug substance, Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	9764003	2033-06-21	U-3161		2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	10888605	2038-08-24	U-3162	Drug product	2021-06-30	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	11752198	2038-08-24	U-3162	Drug product	2023-10-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	12214017	2038-08-24	U-3162	Drug product	2025-03-06	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	12029779	2038-10-10	U-3162		2024-07-09	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	11478533	2040-05-13	U-3861		2025-09-03	`011fe1cb6892…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 11 · 401 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N215256-001	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-001	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-002	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-003	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	D-190	2026-07-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-004	I-973	2028-08-15	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	I-935	2027-03-08	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N215256-005	I-973	2028-08-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-001	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-002	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-003	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	D-190	2026-07-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-004	I-973	2028-08-15	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	NPP	2025-12-23	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	I-935	2027-03-08	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N215256-005	I-973	2028-08-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N215256-001	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-001	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-002	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-002	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-003	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-003	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	D-190	2026-07-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-004	I-935	2027-03-08	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-005	NPP	2025-12-23	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N215256-005	I-935	2027-03-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-001	NPP	2025-12-23	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N215256-001	I-935	2027-03-08	`fd3edfee7708…`

Additional Listing Data#

Finished product: Yes
Brand name base: WEGOVY
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SEMAGLUTIDE	1 mg/.5mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9dd2abc7-744f-456b-a273-dec083824bd8	Product name	2	20240229
487bac84-7c5b-40cf-afd2-8b9674d4648e	Product name	1	20220118
21318a8d-e167-4f44-9627-3daede9532ff	Product name	1	20200227

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0169-4501-01	WEGOVY	0.5 mL in 1 SYRINGE, PLASTIC	INJECTION, SOLUTION	0.5		18
0169-4501-14	WEGOVY	4 in 1 CARTON	INJECTION, SOLUTION	4		18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0169-4501-14	ML - Milliliter	0169-4501	6837bda9-cc73-4acb-bc71-3e13724ae262	1	2021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0169-4501	WEGOVY (SEMAGLUTIDE) INJECTION, SOLUTION [NOVO NORDISK]	10	Current NDC, Legacy NDC, 2 package rows	20241212_ee06186f-2aa3-4990-a760-757579d8f77b.zip

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
WEGOVY	SEMAGLUTIDE	A-S Medication Solutions	f5e548d0-cc79-4c34-a3f5-e20a5b8b6564	2024-04-23	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 215256 application number: NDA215256

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
53AXN4NNHX	SEMAGLUTIDE	910463-68-2	SEMAGLUTIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2553501	semaglutide 0.25 MG in 0.5 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553601	semaglutide 0.5 MG in 0.5 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553802	semaglutide 1 MG in 0.5 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2707547	semaglutide 1.5 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553901	semaglutide 1.7 MG in 0.75 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2554102	semaglutide 2.4 MG in 0.75 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730163	semaglutide 25 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2707551	semaglutide 4 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739768	semaglutide 7.2 MG in 0.75 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2707555	semaglutide 9 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553506	wegovy 0.25 MG in 0.5 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553603	wegovy 0.5 MG in 0.5 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553803	wegovy 1 MG in 0.5 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730161	wegovy 1.5 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553903	wegovy 1.7 MG in 0.75 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2554104	wegovy 2.4 MG in 0.75 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730165	wegovy 25 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730167	wegovy 4 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730169	wegovy 9 MG Oral Tablet	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739771	wegovy HD 7.2 MG in 0.75 ML Auto-Injector	PSN	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553506	0.5 ML semaglutide 0.5 MG/ML Auto-Injector [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553603	0.5 ML semaglutide 1 MG/ML Auto-Injector [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553803	0.5 ML semaglutide 2 MG/ML Auto-Injector [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553903	0.75 ML semaglutide 2.27 MG/ML Auto-Injector [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2554104	0.75 ML semaglutide 3.2 MG/ML Auto-Injector [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739771	0.75 ML semaglutide 9.6 MG/ML Auto-Injector [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730161	semaglutide 1.5 MG Oral Tablet [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730165	semaglutide 25 MG Oral Tablet [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730167	semaglutide 4 MG Oral Tablet [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730169	semaglutide 9 MG Oral Tablet [Wegovy]	SBD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553501	0.5 ML semaglutide 0.5 MG/ML Auto-Injector	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553601	0.5 ML semaglutide 1 MG/ML Auto-Injector	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553802	0.5 ML semaglutide 2 MG/ML Auto-Injector	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553901	0.75 ML semaglutide 2.27 MG/ML Auto-Injector	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2554102	0.75 ML semaglutide 3.2 MG/ML Auto-Injector	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739768	0.75 ML semaglutide 9.6 MG/ML Auto-Injector	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2707547	semaglutide 1.5 MG Oral Tablet	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730163	semaglutide 25 MG Oral Tablet	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2707551	semaglutide 4 MG Oral Tablet	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2707555	semaglutide 9 MG Oral Tablet	SCD	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553501	semaglutide 0.25 MG per 0.5 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553601	semaglutide 0.5 MG per 0.5 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553802	semaglutide 1 MG per 0.5 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553901	semaglutide 1.7 MG per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2554102	semaglutide 2.4 MG per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739768	semaglutide 7.2 MG per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739768	semaglutide 9.6 MG/ML per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553506	Wegovy 0.25 MG per 0.5 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553603	Wegovy 0.5 MG per 0.5 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553803	Wegovy 1 MG per 0.5 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730161	Wegovy 1.5 MG Oral Tablet	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2553903	Wegovy 1.7 MG per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2554104	Wegovy 2.4 MG per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730165	Wegovy 25 MG Oral Tablet	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730167	Wegovy 4 MG Oral Tablet	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739771	Wegovy 7.2 MG per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2730169	Wegovy 9 MG Oral Tablet	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18
2739771	Wegovy 9.6 MG/ML per 0.75 ML Auto-Injector	SY	ee06186f-2aa3-4990-a760-757579d8f77b	18

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0169-4501-01	00169450101	0.5 mL in 1 SYRINGE, PLASTIC	0.5 ml					Historical
0169-4501-14	00169450114	4 SYRINGE, PLASTIC in 1 CARTON (0169-4501-14) / .5 mL in 1 SYRINGE, PLASTIC (0169-4501-01)		2021-06-05	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
WEGOVY	Novo Nordisk Pharmaceutical Industries, LP \| Novo Nordisk A/S - 25a-B	2026-06-18	HUMAN PRESCRIPTION DRUG LABEL	19