Gvoke PFS

Product NDC: 72065-130
11-digit product format: 720650130
Labeler code: 72065
Product ID: 72065-130_f1eb1cb9-848c-cdaf-e053-2995a90a9195
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glucagon injection, solution
Dosage form: INJECTION, SOLUTION
Route: SUBCUTANEOUS
Labeler: Xeris Pharmaceuticals, Inc.
Application: NDA212097
Marketing category: NDA
Marketing start: 2019-09-10
Marketing end: 0000-00-00
Substance: GLUCAGON
Active strength: 1 mg/.1mL
Pharmacologic classes: Antihypoglycemic Agent [EPC], Decreased GI Motility [PE], Decreased GI Smooth Muscle Tone [PE], Decreased Glycolysis [PE], Gastrointestinal Motility Inhibitor [EPC], Increased Gluconeogenesis [PE], Increased Glycogenolysis [PE]
NDC exclude flag: No
Listing certified through: 2024-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	72065-130		D	Discontinued by firm		2026-08-17
excluded package	package	72065-130	72065-130-99	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72065-130-99	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72065-130-99	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72065-130-99	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72065-130-99	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72065-130-99	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72065-130-99	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72065-130-99	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72065-130-99	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72065-130-99	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72065-130-99	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72065-130-99	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72065-130-99	`557ba5c1ecfa…`	`9c80585c8c6e…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
83f7a8cc-8fbf-4478-9a44-b6214b840d9a	Product name	2	20250812
1e832aa0-608b-424f-9ced-615cef2ff5c5	Product name	1	20200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4	Product name	1	20191120
750a4794-c0e1-4ac9-9af5-006ecec3bb04	Product name	1	20150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72065-130-99	Gvoke PFS0.5 mg Pre-filled Syringe	1 in 1 POUCH	INJECTION, SOLUTION	1		20
72065-130-99	Gvoke PFS0.5 mg Pre-filled Syringe	1 in 1 CARTON	INJECTION, SOLUTION	1		20

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72065-130-11	ML - Milliliter	72065-130	77c7f8b3-49aa-4c69-b42c-638b86fd9ace	1	2019-10-07
72065-130-12	ML - Milliliter	72065-130	eccc53f3-099a-4b07-9c54-7612f8dff378	1	2019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72065-130	GVOKE HYPOPEN 1 MG AUTO-INJECTOR (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE HYPOPEN 0.5 MG AUTO-INJECTOR (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE PFS 1 MG PRE-FILLED SYRINGE (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE PFS 0.5 MG PRE-FILLED SYRINGE (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE KIT VIAL (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION GVOKE KIT (GLUCAGON INJECTION, SOLUTION) INJECTION, SOLUTION [XERIS PHARMACEUTICALS, INC.]	17	Legacy NDC, 2 package rows	20250523_92385737-dbad-98c5-e053-2995a90a2805.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 · 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

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
76LA80IG2G	GLUCAGON	16941-32-5	GLUCAGON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2199299	glucagon 0.5 MG in 0.1 mL Auto-Injector	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199310	glucagon 0.5 MG in 0.1 mL Prefilled Syringe	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199307	glucagon 1 MG in 0.2 mL Auto-Injector	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2587358	glucagon 1 MG in 0.2 ML Injection	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199315	glucagon 1 MG in 0.2 mL Prefilled Syringe	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2587361	Gvoke 1 MG in 0.2 ML Injection	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199304	Gvoke HypoPen 0.5 MG in 0.1 mL Auto-Injector	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199308	Gvoke HypoPen 1 MG in 0.2 mL Auto-Injector	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199312	Gvoke PFS 0.5 MG in 0.1 mL Pre-Filled Syringe	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199316	Gvoke PFS 1 MG in 0.2 mL Pre-Filled Syringe	PSN	92385737-dbad-98c5-e053-2995a90a2805	20
2199304	0.1 ML glucagon 5 MG/ML Auto-Injector [Gvoke]	SBD	92385737-dbad-98c5-e053-2995a90a2805	20
2199312	0.1 ML glucagon 5 MG/ML Prefilled Syringe [Gvoke]	SBD	92385737-dbad-98c5-e053-2995a90a2805	20
2199308	0.2 ML glucagon 5 MG/ML Auto-Injector [Gvoke]	SBD	92385737-dbad-98c5-e053-2995a90a2805	20
2587361	0.2 ML glucagon 5 MG/ML Injection [Gvoke]	SBD	92385737-dbad-98c5-e053-2995a90a2805	20
2199316	0.2 ML glucagon 5 MG/ML Prefilled Syringe [Gvoke]	SBD	92385737-dbad-98c5-e053-2995a90a2805	20
2199299	0.1 ML glucagon 5 MG/ML Auto-Injector	SCD	92385737-dbad-98c5-e053-2995a90a2805	20
2199310	0.1 ML glucagon 5 MG/ML Prefilled Syringe	SCD	92385737-dbad-98c5-e053-2995a90a2805	20
2199307	0.2 ML glucagon 5 MG/ML Auto-Injector	SCD	92385737-dbad-98c5-e053-2995a90a2805	20
2587358	0.2 ML glucagon 5 MG/ML Injection	SCD	92385737-dbad-98c5-e053-2995a90a2805	20
2199315	0.2 ML glucagon 5 MG/ML Prefilled Syringe	SCD	92385737-dbad-98c5-e053-2995a90a2805	20
2199304	0.1 ML Gvoke 5 MG/ML Auto-Injector	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199312	0.1 ML Gvoke 5 MG/ML Prefilled Syringe	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199308	0.2 ML Gvoke 5 MG/ML Auto-Injector	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199316	0.2 ML Gvoke 5 MG/ML Prefilled Syringe	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199299	glucagon 0.5 MG per 0.1 mL Auto-Injector	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199310	glucagon 0.5 MG per 0.1 mL Prefilled Syringe	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199307	glucagon 1 MG per 0.2 mL Auto-Injector	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2587358	glucagon 1 MG per 0.2 ML Injection	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199315	glucagon 1 MG per 0.2 mL Prefilled Syringe	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2587358	glucagon 5 MG/ML per 0.2 ML Injection	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2587361	Gvoke 1 MG per 0.2 ML Injection	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2587361	Gvoke 5 MG/ML per 0.2 ML Injection	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199304	Gvoke HypoPen 0.5 MG per 0.1 mL Auto-Injector	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199308	Gvoke HypoPen 1 MG per 0.2 mL Auto-Injector	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199312	Gvoke PFS 0.5 MG per 0.1 mL Pre-Filled Syringe	SY	92385737-dbad-98c5-e053-2995a90a2805	20
2199316	Gvoke PFS 1 MG per 0.2 mL Pre-Filled Syringe	SY	92385737-dbad-98c5-e053-2995a90a2805	20

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
72065-130-11	72065013011	1 POUCH in 1 CARTON (72065-130-11) > 1 SYRINGE, PLASTIC in 1 POUCH > .1 mL in 1 SYRINGE, PLASTIC	1 pouch	2019-09-10	0000-00-00	No	No	Current
72065-130-12	72065013012	2 POUCH in 1 CARTON (72065-130-12) > 1 SYRINGE, PLASTIC in 1 POUCH > .1 mL in 1 SYRINGE, PLASTIC	2 pouch	2019-09-10	0000-00-00	No	No	Current
72065-130-99	72065013099	1 POUCH in 1 CARTON (72065-130-99) > 1 SYRINGE, PLASTIC in 1 POUCH > .1 mL in 1 SYRINGE, PLASTIC	1 pouch	2019-10-28	0000-00-00	Yes	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
glucagon injection, solution	Xeris Pharmaceuticals, Inc.	2025-12-23	HUMAN PRESCRIPTION DRUG LABEL	21