Gvoke VialDx

Product NDC: 0517-2901
11-digit product format: 005172901
Labeler code: 0517
Product ID: 0517-2901_394a5780-8ead-4c26-890c-37edfb879599
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: glucagon injection
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: American Regent, Inc.
Application: NDA212097
Marketing category: NDA
Marketing start: 2025-08-19
Marketing end: 2027-09-30
Substance: GLUCAGON
Active strength: 1 mg/.2mL
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: 2026-12-31
Current FDA listing: 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
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Gvoke VialDx

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
GLUCAGON	1 mg/.2mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
76LA80IG2G	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2587358	Internal RxNorm lookup
2587361	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
359982a8-ec5c-4927-8c0f-89771e0f942b	Available on FDA.report

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	SPL version
0517-2901-01	Gvoke VialDx	0.2 mL in 1 VIAL	INJECTION, SOLUTION	0.2	1
0517-2901-01	Gvoke VialDx	1 in 1 CARTON	INJECTION, SOLUTION	1	1
0517-2901-10	Gvoke VialDx	0.2 mL in 1 VIAL	INJECTION, SOLUTION	0.2	1
0517-2901-10	Gvoke VialDx	10 in 1 CARTON	INJECTION, SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0517-2901-01	ML - Milliliter	0517-2901	bde3f959-b3d8-4d26-8d91-7d7e60c74339	1	2025-09-12
0517-2901-10	ML - Milliliter	0517-2901	3c8a8c14-27da-4a2b-b5d7-236b1e154f7c	1	2025-09-12

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 ndc (product): 0517-2901
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
2587358	glucagon 1 MG in 0.2 ML Injection	PSN	359982a8-ec5c-4927-8c0f-89771e0f942b	1
2587361	Gvoke 1 MG in 0.2 ML Injection	PSN	359982a8-ec5c-4927-8c0f-89771e0f942b	1
2587361	0.2 ML glucagon 5 MG/ML Injection [Gvoke]	SBD	359982a8-ec5c-4927-8c0f-89771e0f942b	1
2587358	0.2 ML glucagon 5 MG/ML Injection	SCD	359982a8-ec5c-4927-8c0f-89771e0f942b	1
2587358	glucagon 1 MG per 0.2 ML Injection	SY	359982a8-ec5c-4927-8c0f-89771e0f942b	1
2587358	glucagon 5 MG/ML per 0.2 ML Injection	SY	359982a8-ec5c-4927-8c0f-89771e0f942b	1
2587361	Gvoke 1 MG per 0.2 ML Injection	SY	359982a8-ec5c-4927-8c0f-89771e0f942b	1
2587361	Gvoke 5 MG/ML per 0.2 ML Injection	SY	359982a8-ec5c-4927-8c0f-89771e0f942b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0517-2901-01	00517290101	1 VIAL in 1 CARTON (0517-2901-01) / .2 mL in 1 VIAL	1 vial	2025-08-19	2027-09-30	No	No	Historical
0517-2901-10	00517290110	10 VIAL in 1 CARTON (0517-2901-10) / .2 mL in 1 VIAL	10 vial	2025-08-19	2027-09-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
glucagon injection	American Regent, Inc. \| PYRAMID Laboratories, Inc.	2026-07-07	HUMAN PRESCRIPTION DRUG LABEL	2