FDA.reportPublic FDA data

Gvoke PFS

Product NDC
72065-131
11-digit product format
720650131
Labeler code
72065
Product ID
72065-131_0b8d0863-8a2a-4a46-9f96-a759f3858bed
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
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Gvoke PFS
Brand name suffix
1 mg Pre-filled Syringe
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLUCAGON1 mg/.2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii76LA80IG2G
Rxcui2199299, 2199304, 2199307, 2199308, 2199310, 2199312, 2199315, 2199316, 2587358, 2587361

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
83f7a8cc-8fbf-4478-9a44-b6214b840d9aProduct name220250812
1e832aa0-608b-424f-9ced-615cef2ff5c5Product name120200220
6ee0758f-9a1a-41ee-90c4-3adce06b52b4Product name120191120
750a4794-c0e1-4ac9-9af5-006ecec3bb04Product name120150608

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72065-131-11Gvoke PFS1 mg Pre-filled Syringe1 in 1 POUCHINJECTION, SOLUTION120
72065-131-11Gvoke PFS1 mg Pre-filled Syringe1 in 1 CARTONINJECTION, SOLUTION120
72065-131-12Gvoke PFS1 mg Pre-filled Syringe1 in 1 POUCHINJECTION, SOLUTION120
72065-131-12Gvoke PFS1 mg Pre-filled Syringe2 in 1 CARTONINJECTION, SOLUTION220
72065-131-99Gvoke PFS1 mg Pre-filled Syringe1 in 1 CARTONINJECTION, SOLUTION120
72065-131-99Gvoke PFS1 mg Pre-filled Syringe1 in 1 POUCHINJECTION, SOLUTION120

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72065-131GVOKE 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.]17Current NDC, Legacy NDC, 6 package rows20250523_92385737-dbad-98c5-e053-2995a90a2805.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2199299glucagon 0.5 MG in 0.1 mL Auto-InjectorPSN92385737-dbad-98c5-e053-2995a90a280520
2199310glucagon 0.5 MG in 0.1 mL Prefilled SyringePSN92385737-dbad-98c5-e053-2995a90a280520
2199307glucagon 1 MG in 0.2 mL Auto-InjectorPSN92385737-dbad-98c5-e053-2995a90a280520
2587358glucagon 1 MG in 0.2 ML InjectionPSN92385737-dbad-98c5-e053-2995a90a280520
2199315glucagon 1 MG in 0.2 mL Prefilled SyringePSN92385737-dbad-98c5-e053-2995a90a280520
2587361Gvoke 1 MG in 0.2 ML InjectionPSN92385737-dbad-98c5-e053-2995a90a280520
2199304Gvoke HypoPen 0.5 MG in 0.1 mL Auto-InjectorPSN92385737-dbad-98c5-e053-2995a90a280520
2199308Gvoke HypoPen 1 MG in 0.2 mL Auto-InjectorPSN92385737-dbad-98c5-e053-2995a90a280520
2199312Gvoke PFS 0.5 MG in 0.1 mL Pre-Filled SyringePSN92385737-dbad-98c5-e053-2995a90a280520
2199316Gvoke PFS 1 MG in 0.2 mL Pre-Filled SyringePSN92385737-dbad-98c5-e053-2995a90a280520
21993040.1 ML glucagon 5 MG/ML Auto-Injector [Gvoke]SBD92385737-dbad-98c5-e053-2995a90a280520
21993120.1 ML glucagon 5 MG/ML Prefilled Syringe [Gvoke]SBD92385737-dbad-98c5-e053-2995a90a280520
21993080.2 ML glucagon 5 MG/ML Auto-Injector [Gvoke]SBD92385737-dbad-98c5-e053-2995a90a280520
25873610.2 ML glucagon 5 MG/ML Injection [Gvoke]SBD92385737-dbad-98c5-e053-2995a90a280520
21993160.2 ML glucagon 5 MG/ML Prefilled Syringe [Gvoke]SBD92385737-dbad-98c5-e053-2995a90a280520
21992990.1 ML glucagon 5 MG/ML Auto-InjectorSCD92385737-dbad-98c5-e053-2995a90a280520
21993100.1 ML glucagon 5 MG/ML Prefilled SyringeSCD92385737-dbad-98c5-e053-2995a90a280520
21993070.2 ML glucagon 5 MG/ML Auto-InjectorSCD92385737-dbad-98c5-e053-2995a90a280520
25873580.2 ML glucagon 5 MG/ML InjectionSCD92385737-dbad-98c5-e053-2995a90a280520
21993150.2 ML glucagon 5 MG/ML Prefilled SyringeSCD92385737-dbad-98c5-e053-2995a90a280520
21993040.1 ML Gvoke 5 MG/ML Auto-InjectorSY92385737-dbad-98c5-e053-2995a90a280520
21993120.1 ML Gvoke 5 MG/ML Prefilled SyringeSY92385737-dbad-98c5-e053-2995a90a280520
21993080.2 ML Gvoke 5 MG/ML Auto-InjectorSY92385737-dbad-98c5-e053-2995a90a280520
21993160.2 ML Gvoke 5 MG/ML Prefilled SyringeSY92385737-dbad-98c5-e053-2995a90a280520
2199299glucagon 0.5 MG per 0.1 mL Auto-InjectorSY92385737-dbad-98c5-e053-2995a90a280520
2199310glucagon 0.5 MG per 0.1 mL Prefilled SyringeSY92385737-dbad-98c5-e053-2995a90a280520
2199307glucagon 1 MG per 0.2 mL Auto-InjectorSY92385737-dbad-98c5-e053-2995a90a280520
2587358glucagon 1 MG per 0.2 ML InjectionSY92385737-dbad-98c5-e053-2995a90a280520
2199315glucagon 1 MG per 0.2 mL Prefilled SyringeSY92385737-dbad-98c5-e053-2995a90a280520
2587358glucagon 5 MG/ML per 0.2 ML InjectionSY92385737-dbad-98c5-e053-2995a90a280520
2587361Gvoke 1 MG per 0.2 ML InjectionSY92385737-dbad-98c5-e053-2995a90a280520
2587361Gvoke 5 MG/ML per 0.2 ML InjectionSY92385737-dbad-98c5-e053-2995a90a280520
2199304Gvoke HypoPen 0.5 MG per 0.1 mL Auto-InjectorSY92385737-dbad-98c5-e053-2995a90a280520
2199308Gvoke HypoPen 1 MG per 0.2 mL Auto-InjectorSY92385737-dbad-98c5-e053-2995a90a280520
2199312Gvoke PFS 0.5 MG per 0.1 mL Pre-Filled SyringeSY92385737-dbad-98c5-e053-2995a90a280520
2199316Gvoke PFS 1 MG per 0.2 mL Pre-Filled SyringeSY92385737-dbad-98c5-e053-2995a90a280520

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72065-131-11720650131111 POUCH in 1 CARTON (72065-131-11) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC1 pouch2019-09-100000-00-00NoNoCurrent
72065-131-12720650131122 POUCH in 1 CARTON (72065-131-12) / 1 SYRINGE, PLASTIC in 1 POUCH / .2 mL in 1 SYRINGE, PLASTIC2 pouch2019-09-100000-00-00NoNoCurrent
72065-131-99720650131991 POUCH in 1 CARTON (72065-131-99) > 1 SYRINGE, PLASTIC in 1 POUCH > .2 mL in 1 SYRINGE, PLASTIC1 pouch2019-10-280000-00-00YesNoCurrent