Home NDC 72065-141 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 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 TE codes 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 Product TE source text 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.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72065-141 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 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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 72065-141-11 72065014111 .2 mL in 1 VIAL, GLASS (72065-141-11) 2021-10-11 0000-00-00 No No Current