Application 212097

Type: NDA
Sponsor: XERIS

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	GVOKE PFS	GLUCAGON	SOLUTION;SUBCUTANEOUS	0.5MG/0.1ML (0.5MG/0.1ML)	Yes	Yes
002	GVOKE PFS	GLUCAGON	SOLUTION;SUBCUTANEOUS	1MG/0.2ML (1MG/0.2ML)	Yes	Yes
003	GVOKE HYPOPEN	GLUCAGON	SOLUTION;SUBCUTANEOUS	0.5MG/0.1ML (0.5MG/0.1ML)	Yes	Yes
004	GVOKE HYPOPEN	GLUCAGON	SOLUTION;SUBCUTANEOUS	1MG/0.2ML (1MG/0.2ML)	Yes	Yes
005	GVOKE KIT	GLUCAGON	SOLUTION;SUBCUTANEOUS	0.5MG/0.1ML (0.5MG/0.1ML)	No	No
006	GVOKE KIT	GLUCAGON	SOLUTION;SUBCUTANEOUS	1MG/0.2ML (1MG/0.2ML)	No	No

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
N212097-001	GVOKE PFS	GLUCAGON	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10
N212097-002	GVOKE PFS	GLUCAGON	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10
N212097-003	GVOKE HYPOPEN	GLUCAGON	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10
N212097-004	GVOKE HYPOPEN	GLUCAGON	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10
N212097-005	GVOKE KIT	GLUCAGON	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20
N212097-006	GVOKE VIALDX	GLUCAGON	1MG/0.2ML (1MG/0.2ML)	SOLUTION / INTRAVENOUS	RLD	2025-03-14

Orange Book patents#

Current patent rows page 1 of 1 · 9 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N212097-001	11590205	2036-04-22	U-2742	Drug product	2023-03-17
N212097-001	9649364	2036-04-22	U-2742	Drug product	2020-02-21
N212097-002	11590205	2036-04-22	U-2742	Drug product	2023-03-17
N212097-002	9649364	2036-04-22	U-2742	Drug product	2020-02-21
N212097-003	11590205	2036-04-22	U-2742	Drug product	2023-03-17
N212097-003	9649364	2036-04-22	U-2742	Drug product	2020-02-21
N212097-004	11590205	2036-04-22	U-2742	Drug product	2023-03-17
N212097-004	9649364	2036-04-22	U-2742	Drug product	2020-02-21
N212097-005	11590205	2036-04-22	U-2742	Drug product	2023-03-17

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 5 · 188 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	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-002	GVOKE PFS	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-003	GVOKE HYPOPEN	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-004	GVOKE HYPOPEN	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-005	GVOKE KIT	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-006	GVOKE VIALDX	1MG/0.2ML (1MG/0.2ML)	SOLUTION / INTRAVENOUS	RLD	2025-03-14	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-002	GVOKE PFS	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-003	GVOKE HYPOPEN	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-004	GVOKE HYPOPEN	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-005	GVOKE KIT	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-006	GVOKE VIALDX	1MG/0.2ML (1MG/0.2ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-03-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-002	GVOKE PFS	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-003	GVOKE HYPOPEN	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-004	GVOKE HYPOPEN	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-005	GVOKE KIT	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-006	GVOKE VIALDX	1MG/0.2ML (1MG/0.2ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-03-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-002	GVOKE PFS	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-003	GVOKE HYPOPEN	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-004	GVOKE HYPOPEN	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-005	GVOKE KIT	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-006	GVOKE VIALDX	1MG/0.2ML (1MG/0.2ML)	SOLUTION / INTRAVENOUS	RLD, RS	2025-03-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-002	GVOKE PFS	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-003	GVOKE HYPOPEN	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-004	GVOKE HYPOPEN	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-005	GVOKE KIT	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212097-002	GVOKE PFS	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212097-003	GVOKE HYPOPEN	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212097-004	GVOKE HYPOPEN	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N212097-005	GVOKE KIT	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212097-002	GVOKE PFS	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212097-003	GVOKE HYPOPEN	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212097-004	GVOKE HYPOPEN	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2019-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N212097-005	GVOKE KIT	1MG/0.2ML (1MG/0.2ML)	SOLUTION / SUBCUTANEOUS	RLD, RS	2021-08-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N212097-001	GVOKE PFS	0.5MG/0.1ML (0.5MG/0.1ML)	SOLUTION / SUBCUTANEOUS	RLD	2019-09-10	`2680178bc6a6…`

Observed Orange Book patent history#

Patent history page 1 of 7 · 271 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	N212097-001	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-001	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-002	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-002	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-003	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-003	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-004	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-004	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N212097-005	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N212097-001	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-001	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-002	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-002	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-003	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-003	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-004	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-004	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N212097-005	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-001	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-001	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-002	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-002	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-003	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-003	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-004	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-004	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N212097-005	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N212097-001	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-001	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-002	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-002	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-003	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-003	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-004	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-004	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N212097-005	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-001	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-001	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-002	11590205	2036-04-22	U-2742	Drug product	2023-03-17	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N212097-002	9649364	2036-04-22	U-2742	Drug product	2020-02-21	`fd3edfee7708…`

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212097-001	NP	2022-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212097-002	NP	2022-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212097-003	NP	2022-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N212097-004	NP	2022-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N212097-001	NP	2022-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212097-002	NP	2022-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212097-003	NP	2022-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N212097-004	NP	2022-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N212097-001	NP	2022-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212097-002	NP	2022-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212097-003	NP	2022-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N212097-004	NP	2022-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N212097-001	NP	2022-09-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212097-002	NP	2022-09-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212097-003	NP	2022-09-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N212097-004	NP	2022-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N212097-001	NP	2022-09-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212097-002	NP	2022-09-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212097-003	NP	2022-09-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N212097-004	NP	2022-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N212097-001	NP	2022-09-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212097-002	NP	2022-09-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212097-003	NP	2022-09-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N212097-004	NP	2022-09-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212097-001	NP	2022-09-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212097-002	NP	2022-09-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212097-003	NP	2022-09-10	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N212097-004	NP	2022-09-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N212097-001	NP	2022-09-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212097-002	NP	2022-09-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212097-003	NP	2022-09-10	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N212097-004	NP	2022-09-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N212097-001	NP	2022-09-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212097-002	NP	2022-09-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212097-003	NP	2022-09-10	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N212097-004	NP	2022-09-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N212097-001	NP	2022-09-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212097-002	NP	2022-09-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212097-003	NP	2022-09-10	`c0c555d07b60…`
2020-11-12 02:37 UTC	2020-11	N212097-004	NP	2022-09-10	`c0c555d07b60…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gvoke VialDx	GLUCAGON INJECTION	American Regent, Inc.	359982a8-ec5c-4927-8c0f-89771e0f942b	2026-07-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212097 application number: NDA212097
Gvoke HypoPen 0.5 mg Auto-Injector	GLUCAGON INJECTION, SOLUTION	Xeris Pharmaceuticals, Inc.	92385737-dbad-98c5-e053-2995a90a2805	2025-12-23	Warnings, Adverse reactions	Exact identifier application applno (NDA): 212097 application number: NDA212097 ndc (product): 72065-120 ndc (product): 72065-131 ndc (product): 72065-140 ndc (product): 72065-121

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 48 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-120	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-121	Gvoke HypoPen	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-130	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-131	Gvoke PFS	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-140	Gvoke Kit	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-140	Gvoke Kit	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-141	Gvoke Kit	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current
72065-141	Gvoke Kit	glucagon injection, solution	Xeris Pharmaceuticals, Inc.	NDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
81641	SUPPL	2025-03-18
81621	SUPPL	2025-03-18
77174	SUPPL	2024-01-02
77140	SUPPL	2023-12-27
68449	SUPPL	2021-08-24
68440	SUPPL	2021-08-22
68138	SUPPL	2021-07-20
68112	SUPPL	2021-07-19
62470	SUPPL	2020-04-08
61943	ORIG	2020-02-21
59952	ORIG	2019-12-18
59970	ORIG	2019-09-11
63059	ORIG	1900-01-01
63058	ORIG	1900-01-01
63057	ORIG	1900-01-01
63056	ORIG	1900-01-01