Gvoke Kit

Product NDC
72065-141
11-digit product format
720650141
Labeler code
72065
Product ID
72065-141_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
2021-10-11
Marketing end
0000-00-00
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
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct72065-141DDiscontinued by firm2026-08-17
excluded packagepackage72065-14172065-141-11DDiscontinued by firm2026-08-17

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N212097-001GVOKE PFSGLUCAGON0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-10
N212097-002GVOKE PFSGLUCAGON1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10
N212097-003GVOKE HYPOPENGLUCAGON0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10
N212097-004GVOKE HYPOPENGLUCAGON1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10
N212097-005GVOKE KITGLUCAGON1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-20
N212097-006GVOKE VIALDXGLUCAGON1MG/0.2ML (1MG/0.2ML)SOLUTION / INTRAVENOUSRLD2025-03-14

Orange Book patents#

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

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N212097-001115902052036-04-22U-2742Drug product2023-03-17
N212097-00196493642036-04-22U-2742Drug product2020-02-21
N212097-002115902052036-04-22U-2742Drug product2023-03-17
N212097-00296493642036-04-22U-2742Drug product2020-02-21
N212097-003115902052036-04-22U-2742Drug product2023-03-17
N212097-00396493642036-04-22U-2742Drug product2020-02-21
N212097-004115902052036-04-22U-2742Drug product2023-03-17
N212097-00496493642036-04-22U-2742Drug product2020-02-21
N212097-005115902052036-04-22U-2742Drug product2023-03-17

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-002GVOKE PFS1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-003GVOKE HYPOPEN0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-004GVOKE HYPOPEN1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-005GVOKE KIT1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-20caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-006GVOKE VIALDX1MG/0.2ML (1MG/0.2ML)SOLUTION / INTRAVENOUSRLD2025-03-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-002GVOKE PFS1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-003GVOKE HYPOPEN0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-004GVOKE HYPOPEN1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-005GVOKE KIT1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-20011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-006GVOKE VIALDX1MG/0.2ML (1MG/0.2ML)SOLUTION / INTRAVENOUSRLD, RS2025-03-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-002GVOKE PFS1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-003GVOKE HYPOPEN0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-004GVOKE HYPOPEN1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-1031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-005GVOKE KIT1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-2031067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-006GVOKE VIALDX1MG/0.2ML (1MG/0.2ML)SOLUTION / INTRAVENOUSRLD, RS2025-03-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-002GVOKE PFS1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-003GVOKE HYPOPEN0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-004GVOKE HYPOPEN1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-106a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-005GVOKE KIT1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-206a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-006GVOKE VIALDX1MG/0.2ML (1MG/0.2ML)SOLUTION / INTRAVENOUSRLD, RS2025-03-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-002GVOKE PFS1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-003GVOKE HYPOPEN0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-004GVOKE HYPOPEN1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-005GVOKE KIT1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-20fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212097-002GVOKE PFS1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212097-003GVOKE HYPOPEN0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212097-004GVOKE HYPOPEN1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-10b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N212097-005GVOKE KIT1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-20b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212097-002GVOKE PFS1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212097-003GVOKE HYPOPEN0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212097-004GVOKE HYPOPEN1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2019-09-1003ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N212097-005GVOKE KIT1MG/0.2ML (1MG/0.2ML)SOLUTION / SUBCUTANEOUSRLD, RS2021-08-2003ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N212097-001GVOKE PFS0.5MG/0.1ML (0.5MG/0.1ML)SOLUTION / SUBCUTANEOUSRLD2019-09-102680178bc6a6…

Observed Orange Book patent history#

Patent history page 1 of 7 · 271 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N212097-001115902052036-04-22U-2742Drug product2023-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-00196493642036-04-22U-2742Drug product2020-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-002115902052036-04-22U-2742Drug product2023-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-00296493642036-04-22U-2742Drug product2020-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-003115902052036-04-22U-2742Drug product2023-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-00396493642036-04-22U-2742Drug product2020-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-004115902052036-04-22U-2742Drug product2023-03-17caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-00496493642036-04-22U-2742Drug product2020-02-21caaa826d4ba7…
2026-08-18 06:07:402026-07N212097-005115902052036-04-22U-2742Drug product2023-03-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N212097-001115902052036-04-22U-2742Drug product2023-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-00196493642036-04-22U-2742Drug product2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-002115902052036-04-22U-2742Drug product2023-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-00296493642036-04-22U-2742Drug product2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-003115902052036-04-22U-2742Drug product2023-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-00396493642036-04-22U-2742Drug product2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-004115902052036-04-22U-2742Drug product2023-03-17011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-00496493642036-04-22U-2742Drug product2020-02-21011fe1cb6892…
2026-02-19 14:30 UTC2026-02N212097-005115902052036-04-22U-2742Drug product2023-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-001115902052036-04-22U-2742Drug product2023-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-00196493642036-04-22U-2742Drug product2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-002115902052036-04-22U-2742Drug product2023-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-00296493642036-04-22U-2742Drug product2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-003115902052036-04-22U-2742Drug product2023-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-00396493642036-04-22U-2742Drug product2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-004115902052036-04-22U-2742Drug product2023-03-1731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-00496493642036-04-22U-2742Drug product2020-02-2131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N212097-005115902052036-04-22U-2742Drug product2023-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N212097-001115902052036-04-22U-2742Drug product2023-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-00196493642036-04-22U-2742Drug product2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-002115902052036-04-22U-2742Drug product2023-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-00296493642036-04-22U-2742Drug product2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-003115902052036-04-22U-2742Drug product2023-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-00396493642036-04-22U-2742Drug product2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-004115902052036-04-22U-2742Drug product2023-03-176a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-00496493642036-04-22U-2742Drug product2020-02-216a471c1ec25d…
2025-08-23 18:47 UTC2025-08N212097-005115902052036-04-22U-2742Drug product2023-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-001115902052036-04-22U-2742Drug product2023-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-00196493642036-04-22U-2742Drug product2020-02-21fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-002115902052036-04-22U-2742Drug product2023-03-17fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N212097-00296493642036-04-22U-2742Drug product2020-02-21fd3edfee7708…

Observed Orange Book exclusivity history#

Exclusivity history page 1 of 2 · 64 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212097-001NP2022-09-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212097-002NP2022-09-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212097-003NP2022-09-105c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N212097-004NP2022-09-105c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N212097-001NP2022-09-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N212097-002NP2022-09-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N212097-003NP2022-09-105d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N212097-004NP2022-09-105d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N212097-001NP2022-09-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N212097-002NP2022-09-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N212097-003NP2022-09-104b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N212097-004NP2022-09-104b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N212097-001NP2022-09-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N212097-002NP2022-09-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N212097-003NP2022-09-1074a2ff9319b5…
2019-12-13 00:20 UTC2019-12N212097-004NP2022-09-1074a2ff9319b5…
2022-03-09 01:35 UTC2022-03N212097-001NP2022-09-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N212097-002NP2022-09-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N212097-003NP2022-09-10bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N212097-004NP2022-09-10bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N212097-001NP2022-09-10782e0a99824c…
2021-12-28 21:50 UTC2021-12N212097-002NP2022-09-10782e0a99824c…
2021-12-28 21:50 UTC2021-12N212097-003NP2022-09-10782e0a99824c…
2021-12-28 21:50 UTC2021-12N212097-004NP2022-09-10782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212097-001NP2022-09-1087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212097-002NP2022-09-1087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212097-003NP2022-09-1087673890dc5c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N212097-004NP2022-09-1087673890dc5c…
2021-03-12 10:30 UTC2021-03N212097-001NP2022-09-105aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N212097-002NP2022-09-105aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N212097-003NP2022-09-105aa47cf7b7d7…
2021-03-12 10:30 UTC2021-03N212097-004NP2022-09-105aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N212097-001NP2022-09-108869cabd3fbd…
2020-12-22 03:56 UTC2020-12N212097-002NP2022-09-108869cabd3fbd…
2020-12-22 03:56 UTC2020-12N212097-003NP2022-09-108869cabd3fbd…
2020-12-22 03:56 UTC2020-12N212097-004NP2022-09-108869cabd3fbd…
2020-11-12 02:37 UTC2020-11N212097-001NP2022-09-10c0c555d07b60…
2020-11-12 02:37 UTC2020-11N212097-002NP2022-09-10c0c555d07b60…
2020-11-12 02:37 UTC2020-11N212097-003NP2022-09-10c0c555d07b60…
2020-11-12 02:37 UTC2020-11N212097-004NP2022-09-10c0c555d07b60…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72065-141-11ML - Milliliter72065-141b3035711-cfb5-4005-9ba3-15b53221f7e912021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72065-141GVOKE 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.]17Legacy NDC20250523_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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gvoke VialDxGLUCAGON INJECTIONAmerican Regent, Inc.359982a8-ec5c-4927-8c0f-89771e0f942b2026-07-07Warnings, Adverse reactionsExact identifier
application applno (NDA): 212097
application number: NDA212097
Gvoke HypoPen 0.5 mg Auto-InjectorGLUCAGON INJECTION, SOLUTIONXeris Pharmaceuticals, Inc.92385737-dbad-98c5-e053-2995a90a28052025-12-23Warnings, Adverse reactionsExact identifier
application applno (NDA): 212097
application number: NDA212097

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72065-141-1172065014111.2 mL in 1 VIAL, GLASS (72065-141-11) 2021-10-110000-00-00NoNoCurrent